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Cervical cancer prevention and early detection

Study sites:	Ireland
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	PIs from collaborating institutions: Project manager: Walter Prendiville (IARC) Project sponsor in Ireland: Fiona Murphy (NSS) Project coordinator in Ireland: Grace Turner (NSS) Project team at IARC: Clément Chauvet Andre Carvalho Anouk Berger Véronique Terrasse Arunah Chandran Eric Lucas Krittika Guinot
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Start date:	2021
Closure date:	Ongoing
Objectives:	To support Ireland in delivering an exemplar Cervical Cancer Screening Programme for their population and to identify global best practices for audit of screening programmes
Methodology:	As part of the initiative, three Technical Working Groups (TWGs) with experts in the areas of public health, cancer screening implementation and quality improvement, health communication, national and international laws governing relevant medico-legal issues and regulations in data protection will be formed to achieve the following: TWG 1: To develop best practices for conducting interval cancer audit in cervical cancer screening programmes TWG 2: To bring out good practices and key considerations including a checklist for transparent & pragmatic communication with public, service providers & other stakeholders (related to benefits, inadequacies & harms of cervical cancer screening) TWG 3: To develop best practices and a legal framework that will better safeguard the interests of screening participants, providers, and managers The best practice strategies identified by the TWGs will be contextualized to the screening programme organization, barriers, and facilitators (at the levels of service users, service providers and health system) and stakeholders’ expectations in Ireland through engagement with a Stakeholders’ Advisory Group (SAG) from the country.
Funding:	Department of Health, Ireland

Study sites:	India: Ahmedabad, Aizawl, Ambilikkai, Barshi, Hyderabad, Kolkata, Mumbai, New Delhi, Pune, Sikkim, Thiruvananthapuram
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Geeta Joshi, Gujarat Cancer & Research Institute (GCRI), Ahmedabad Eric Zomawia, Civil Hospital, Aizawl, Mizoram Pulikattil Okkaru Esmy, Christian Fellowship Community Health Centre (CFCHC), Ambilikkai S. Malvi, Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi P. Usha Rani Reddy Poli, Mehdi Nawaj Jung Cancer Institute (MNJCI), Hyderabad Maqsood Siddiqi, Cancer Foundation of India (CFI), Kolkata Sharmila Pimple, Tata Memorial Centre (TMC), Mumbai Neerja Bhatla, All India Institute of Medical Science (AIIMS), New Delhi Smita Joshi, Jehangir Clinical Development Centre (JCDC), Pune Yogesh Verma, Sir Thodup Namgyal Memorial Hospital (STNM), Gangtok, Sikkim M. Radhakrishna Pillai, Rajiv Gandhi Centre for Biotechnology (RGCB), Thiruvananthapuram
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Start date:	2016
Closure date:	Ongoing
Objectives:	To conduct long-term follow-up of the vaccinated cohorts to document medically significant events occurring 5–10 years after HPV vaccination To carry out annual HPV detection and genotyping in the vaccinated and unvaccinated cohorts to assess the protection offered by the vaccine against incident and persistent infections To evaluate the protection provided by the vaccine against the development of high-grade cervical premalignant lesions To evaluate memory B-cell and adaptive T-cell response against target HPV types in the vaccinated cohorts To study the immune correlate of protection for the HPV vaccine
Publications:	Ringborg U., Berns A., Celis J.E., Heitor M., Tabernero J., Schüz J., Baumann M., Henrique R., Aapro M., Basu P., Beets-Tan R., Besse B., Cardoso F., Carneiro F., van den Eede G., Eggermont A., Fröhling S., Galbraith S., Garralda E., Hanahan D., Hofmarcher T., Jönsson B., Kallioniemi O., Kásler M., Kondorosi E., Korbel J., Lacombe D., Carlos Machado J., Martin-Moreno J.M., Meunier F., Nagy P., Nuciforo P., Oberst S., Oliveiera J., Papatriantafyllou M., Ricciardi W., Roediger A., Ryll B., Schilsky R., Scocca G., Seruca R., Soares M., Steindorf K., Valentini V., Voest E., Weiderpass E., Wilking N., Wren A., Zitvogel L. The Porto European Cancer Research Summit 2021. Mol Oncol. 2021 Sep 13. doi: 10.1002/1878-0261.13078. PMID: 34515408 Bhatla N., Nene B.M., Joshi S., Esmy P.O., Poli U.R.R., Joshi G., Verma Y., Zomawia E., Pimple S., Prabhu P.R., Basu P., Muwonge R., Hingmire S., Sauvaget C., Lucas E., Pawlita M., Gheit T., Jayant K., Malvi S.G., Siddiqi M., Michel A., Butt J., Sankaran S., Kannan T.P.R.A., Varghese R., Divate U., Willhauck-Fleckenstein M., Waterboer T., Müller M., Sehr P., Kriplani A., Mishra G., Jadhav R., Thorat R., Tommasino M., Pillai M.R., Sankaranarayanan R.; Indian HPV vaccine study group. Are two doses of human papillomavirus vaccine sufficient for girls aged 15-18 years? Results from a cohort study in India. Papillomavirus Res. 2018 Jun;5:163-171. PMID: 29578097 Sankaranarayanan R., Joshi S., Muwonge R., Esmy P.O., Basu P., Prabhu P., Bhatla N., Nene B.M., Shaw J., Poli U.R.R., Verma Y., Zomawia E., Pimple S., Tommasino M., Pawlita M., Gheit T., Waterboer T., Sehr P., Pillai M.R.; Indian HPV vaccine study group. Can a single dose of human papillomavirus (HPV) vaccine prevent cervical cancer? Early findings from an Indian study. Vaccine. 2018 Aug 6;36(32 Pt A):4783-4791. PMID: 29551226 Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow up cohort study. Basu P., Muwonge R., Bhatla N., Nene B.M., Joshi S., Esmy P.O., Poli U.R.R., Joshi G., Verma Y., Zomawia E., Shastri S.S., Pimple S., Anantharaman D., Prabhu P.R., Hingmire S., Sauvaget C., Lucas E., Pawlita M., Gheit T., Jayant K., Malvi S.G., Siddiqi M., Michel A., Butt J., Sankaran S., Rameshwari Ammal Kannan T.P., Varghese R., Divate U., Willhauck-Fleckenstein M., Waterboer T., Müller M., Sehr P., Vashist S., Mishra G., Jadhav R., Thorat R., Tommasino M., Pillai M.R., Sankaranarayanan R.; Indian HPV vaccine study group. Papillomavirus Res. 2019 Jan 31. pii: S2405-8521(18)30133-2. PMID: 30711698
Funding:	Bill & Melinda Gates Foundation

Study sites:	Benin, Cameroon, Côte d’Ivoire and Senegal
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Rachid Bekkali and Youssef Chami, Lalla Salma Foundation for Cancer Prevention and Treatment, Morocco Dr Djima Patrice Dangbèmey, Benin Dr Nkele Ndeki Ngoh, Cameroon Dr Denise Kpebo, Côte d’Ivoire Dr Yacine Dieng, Senegal
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Start date:	2017
Closure date:	Ongoing
Objectives:	The third edition of the World Bank’s publication “Disease Control Priorities” recommends opportunistic screening using visual inspection with acetic acid (VIA) and treatment of precancerous lesions (the screen-and-treat approach) as part of an essential package of health interventions in low-income countries. But very few countries in sub-Saharan Africa have taken steps to introduce such screen-and-treat programmes. The experience gained from properly implemented pilot projects in these countries will inform pragmatic decision-making by policy-makers in scaling up the programmes. The Disease Control Priorities project also identified early diagnosis of women with breast symptoms linked with access to good-quality treatment as the most practical strategy to tackle the growing burden of breast cancer in countries with limited-resource settings. The primary objectives of the CARE4Afrique study are to implement and evaluate pilot projects using the VIA screen-and-treat approach, and to increase breast cancer early diagnosis capacity in Benin, Cameroon, Côte d’Ivoire and Senegal. The study will also evaluate some novel approaches, such as the use of thermocoagulation for the treatment of eligible VIA-positive women.
Methodology:	In consultation with the respective Ministries of Health, the study investigators are in the process of selecting two to three primary health centres/district hospitals in each participating country, where trained nurses will provide VIA screen-and-treat services to women aged 30–49 years. The investigators will also identify a diagnostic facility in each country where screen-positive women not eligible for thermocoagulation will be referred for colposcopy and treatment. Women with suspected invasive cancers will be referred directly to an oncology centre. Screen-negative women will be advised to undergo repeat VIA after 5 years, unless they are known to be HIV-positive, in which case they will be advised to undergo screening every 3 years. All treated women will be advised to receive follow-up after 1 year. Two master trainers from each country will be trained in a week-long course on cervical cancer prevention, early detection, and management. The master trainers will then train the nurses, general practitioners, and gynaecologists in their respective countries. Programme monitoring will be carried out on a regular basis to assess the following indicators: monthly screening rate, VIA positivity rate, overall treatment rate, same-day treatment rate, and compliance with follow-up. The cure rate at 1 year after thermocoagulation will also be estimated. To increase the capacity of at least one tertiary oncology care centre in each country to diagnose breast cancer early, one master trainer in radiology and one master trainer in pathology from each tertiary oncology centre will be trained in breast radiology and breast pathology in Morocco.
Funding:	Lalla Salma Foundation for Cancer Prevention and Treatment
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Study sites:	Lusaka, Zambia
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	G. Parham, Cervical Cancer Prevention Program, Centre for Infectious Disease Research in Zambia, Lusaka, Zambia Walter Prendiville, International Federation of Cervical Pathology and Colposcopy, Frederick MD, USA
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Start date:	2016
Closure date:	Ongoing
Objectives:	To develop and evaluate a cordless, lightweight, rechargeable, hand-held thermal coagulator for the treatment of cervical precancerous lesions in low- and middle-income countries (LMICs) and, if the device is validated, to make it available at an affordable price specifically for LMICs To evaluate a safe method for reducing overtreatment of visual inspection with acetic acid (VIA)–positive women using the ZedScan biophysical device The study design contains two phases: an exploratory UH2 phase and a randomized controlled trial UH3 phase.
Methodology:
ClinicalTrials.gov identifier:	NCT02956239
Publications:	Pinder L.F., Parham G.P., Basu P., Muwonge R., Lucas E., Nyambe N., Sauvaget C., Mwanahamuntu M.H., Sankaranarayanan R., Prendiville W. Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial. Lancet Oncol. 2019 Nov 13. pii: S1470-2045(19)30635-7. PMID: 31734069
Funding:	United States National Institutes of Health (NIH)
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Study sites:	Tamil Nadu and Mizoram, India
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Anu Mary Oomen ( Christian Medical College, Vellore, Tamil Nadu, India) Julia Brotherton (The University of Melbourne, Australia)
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Start date:	2022
Closure date:	Ongoing
Objectives:	The project will draw on international and local learnings and will engage with stakeholders in India to co-design, implement, and evaluate multiple implementation approaches to screen vulnerable populations (tribal, rural, and urban slum dwellers), in Tamil Nadu and Mizoram, with an HPV test.
Methodology:	Settings: five sites, across two states of India, which reflect some of the diverse environments where vulnerable populations reside (Tamil Nadu in Southern India and Mizoram in North-eastern India). Strategy: Situational analysis, Co-Design of Interventions, Strategic Action and evaluation.
Publications:	Oommen A.M., Basu P., Cherian A.G., Zomawia E., Manoharan R., Pricilla R.A., Viswanathan V., Oldenburg B., Subramanian S., Hawkes D., Saville M., Brotherton J.M.L.; SHE-CAN collaborators. Protocol for the formative phase of a trial (SHE-CAN) to test co-designed implementation strategies for HPV-based cervical screening among vulnerable women in two diverse settings in India. Implement Sci Commun. 2023 Jun 8;4(1):62. PMID: 37291627
Funding:	National Health and Medical Research Council, Australia, as part of the sixth call by the Global Alliance for Chronic Diseases (GACD), for cancer

Study sites:	India: Chennai, New Delhi, Kolkata, Thailand: Bangkok
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Dr Neerja Bhatla, All India Institute of Medical Sciences, New Delhi, India Dr J.S. Malliga, Cancer Institute (WIA) Chennai, Chennai, India Dr Ranajit Mandal, Chittaranjan National Cancer Institute (CNCI), Kolkata, India Dr Suleeporn Sangararang, National Cancer Institute, Bangkok, Thailand
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Start date:	2021
Closure date:	Ongoing
Objectives:	To determine the test characteristics of Automated Visual Evaluation in a screening context: To estimate the sensitivity and specificity of Automated Visual Evaluation to detect cervical intraepithelial neoplasia (CIN) 2 or worse (HSIL) compared to high risk HPV testing where both are a primary screening technique. To determine the test characteristics of Automated Visual Evaluation in a triage context: To estimate and compare the sensitivity and specificity of Automated Visual Evaluation to detect CIN 2 or worse when compared to colposcopy as a triaging technique of HPV positive women. To compare the relative value of Automated Visual Evaluation as a diagnostic tool in screen positive women: To compare the efficacy of Automated Visual Evaluation with colposcopy in correctly discriminating between the CIN 2+ and normal/low-grade CIN lesions in HPV+ve women. To assess the efficacy of Automated Visual Evaluation in correctly defining the Transformation Zone type and thus eligibility for ablation or excision) in women requiring treatment.
Methodology:	The Indian study sites screen 30-59-year-old women using HPV testing. In these centres screen positive women are evaluated with colposcopy prior to treatment. The present study will be integrated to these existing screening programme. The study will be implemented in screening settings in India and colposcopy clinics in Thailand: In Thailand the study will be implemented at the colposcopy clinic where women with positive HPV test and cytology test are referred for colposcopy. Images of the cervix will be captured with the Automated Visual Evaluation device. The AI built into the device will interpret the images and decide on the location of SCJ, type of TZ, presence of abnormal lesions, the most appropriate site for biopsy and suitability for ablative treatment (based on TZ type, size and grade of lesion), but the clinician will be blinded to these outcomes. The clinician will independently document the visibility and location of the SCJ, type of TZ, Swede score, most appropriate site for taking biopsy (if any abnormalities are present) and suitability for treatment by ablation. At the end of the examination the clinician will take at least one punch biopsy from the most abnormal site determined by him/her based on Swede score (>=5). The examining clinician will be blinded to all information collected by the device until the end of the study.
Funding:	Intramural funds from IARC

Study sites:	Occitanie region, France
Principal investigator (PI) from IARC:	F. Selmouni
PIs from collaborating institutions:	Dr Antoine Kreiche, Regional Cancer Screening Management Center of Occitanie region (CRCDC-OC) Prof. Abdelhak Nassiri, Université de Bretagne Occidentale
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Start date:	2021
Closure date:	Ongoing
Objectives:	Improve participation in cervical cancer screening among socially disadvantaged women who have not been followed up in the Occitanie region Reduce morbidity and social inequalities linked to cervical cancer
Methodology:	This is a two-arm cluster randomized-controlled trial within the French organized cervical screening programme among non-responders living in deprived areas in Occitanie Region-France. A cluster is defined by aggregated units for statistical information (IRIS) and which refers to the target size of 2000 inhabitants per basic unit. Only IRIS classified 4 and 5 according to the French version of the European Deprivation Index will be included. The clusters will be stratified by population density, medical density, and environment (urban or rural).The intervention will consist in sending HPV self-sampling kit at home and in providing through multiple mobile channels (SMS messages, web, social media, or mobile apps), a multi-language decision aid designed for women with lower education. Women in the experimental group will be sent screening reminder letters to perform self-sampling for HPV, associated with an access via Chatbot platforms to the tailored decision aid. The active control group will receive the reminder letters with a HPV self-sampling kit. The intervention will be evaluated by comparing the "return" rate of HPV self-samples and the proportion of invited women "well managed" between both groups. Economic evaluation using cost-efficacy analysis of this intervention will also be conducted.
Funding:	National Cancer Institute (INCa), France

Study sites:	India: Bangalore, Chandigarh, New Delhi, Hyderabad, Mangalore, Mumbai, Pune, Vadu, Vellore
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Dr Neerja Bhatla, All India Institute of Medical Sciences, New Delhi, India Dr Smita Joshi, Grant Medical Foundation (Ruby Hall Clinic), Pune, India Dr J.S. Malliga, Cancer Institute (WIA) Chennai, Chennai, India Dr Ranajit Mandal, Chittaranjan National Cancer Institute (CNCI), Kolkata, India Dr Ashrafun Nessa, Bangabandhu Sheikj Mujib Medical University (BSMMU), Dhaka, Bangladesh Dr Suleeporn Sangararang, National Cancer Institute, Bangkok, Thailand
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Start date:	2018
Closure date:	Ongoing
Objectives:	HPV vaccines are widely recommended for prevention of cervical cancer and can be a highly cost-effective in the LMICs provided the cost per dose of the vaccine is ~3 USD. Currently most of the LMICs pay ~10USD per dose of the HPV vaccine for their national immunization programs. Serum Institute of India Limited (SIIL) is the largest supplier of all UNICEF procured vaccines for the LMICs. SIIL has formulated and developed a vaccine against HPV 6/11/16/18 (SIIL-qHPV) that is likely to be cheaper than the existing HPV vaccines due to a novel production system and indigenous production in India. This vaccine has been successfully tested in phase I trial on human volunteers and has been considered as safe. For the purpose of licensure the vaccine has to prove its safety in a phase II randomized trial and efficacy and safety in a phase III randomized trial. The composition of SIIPL vaccine is similar to Gardasil (Merck), thus comparable results in terms of safety, reactogenicity are expected with the investigational vaccine. The licensing authority in India (Drug Controller General of India) agreed to provide license to the new vaccine if its immunogenicity (antibody response) can be proved to be non-inferior to that of Gardasil and if the vaccine has similar safety profile as that of Gardasil. So the current Phase II/III study will compare the safety and immunogenicity of the SIIL-qHPV with those of Gardasil in girls and boys aged 9-14 years (2-dose cohort) and in men and women aged 15-26 years (3-dose cohort).
Methodology:	The details of the methodology of the phase II/Phase III trial is available at: clinical trials registry, India. IARC is providing technical support to plan and implement the study and analyse the results.
Funding:	Bill & Melinda Gates Foundation

Study sites:	Estonia, Portugal and Romania
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Dr Marc Bardou, Institut national de la santé et de la recherche médicale (Inserm), France Dr Berit Andersen, region Midtjulland, Regionshospitalet Randers (RHR), Department of Public Health Programmes, Denmark Dr Rosa Legood, London School of Hygiene and Tropical Medicine Royal Charter (LSHTM), United Kingdom Dr Paolo Giorgi Rossi, Azienda Unità Sanitaria Locale-di Reggio Emilia (AUSL-IRCCS), Italy Dr Nuno Lunet, Instituto de Saúde Pública da Universidade do Porto (ISPUP), Portugal Dr Anneli Uusküla, University of Tartu Ulikool (UTARTU), Estonia Dr Adriana Baban, Universitatea Babes-Bolyai (UBB), Romania Dr Florian Alexandru Nicula, Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca (IOCN), Romania Dr Vanessa Moore, European Institute of Women's Health company limited by guarantee (EIWH), United Kingdom Dr Lise Rochaix, Ecole d'economie de Paris (PSE), France Dr Irina Todorova, Nauchno-Uzsledovatelski Centre Psihologiya I Zdrave Fondatsiya (HPRC), Bulgaria Dr David Ritchie, Association Europenne des Ligues contre le cancer ASBL (ECL), Belgium Dr Christiane Dascher-Nadel, Inserm Transfert SA (IT), France
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Start date:	2020
Closure date:	Ongoing
Objectives:	Though cervical cancer screening (CCS) programmes drastically reduce cervical cancer mortality, they remain largely inaccessible and underused by subpopulations of vulnerable women, creating inequality in the European healthcare system. Our multi-centric implementation research study aims to tackle inequality in CCS continuum in Estonia, Portugal and Romania. These ‘focus countries’ have been identified to represent different healthcare settings within Europe.
Methodology:	CBIG-SCREEN will create a Europe-wide knowledge framework around barriers to CCS and generate policies, programmes, communications and other required services to meet the needs of underserved women with inherent high-risk of cervical cancer and low access to proper healthcare routes. CBIG-SCREEN will be working collaboratively with vulnerable and underserved women to identify the interventions that will more effectively engage and retain them in CCS programmes in the three countries. We will design a protocol of providing CCS services to the vulnerable women through stakeholder engagement and structured reviews of current policies. We will implement CCS with new protocol in real programmatic settings in the focus countries and measure the outcomes using the ‘logic model’, A comparison with the existing ‘standard-of-care’ will allow us to objectively document the improvement in participation of the vulnerable women to the entire CCS care continuum, starting from screening to treatment. View the CBIG-SCREEN Study consortium website.
Study outcomes:	Our interventions aim to increase screening participation among vulnerable women from current 26% to 45% and intend to offer support to policymakers and national programmes to help Europe reach the WHO 2030 target of screening >70% of women for cervical cancer.
Funding:	European Commission - Research and Innovation (BE)

Study sites:	Lyon, France
Principal investigator (PI) from IARC:	P. Villain
PIs from collaborating institutions:	Pr Marie Préau, Dr Arnaud Simeone, Dr Julien Biaudet, Pr Chauvin
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Start date:	2017
Closure date:	Ongoing
Objectives:	The PAPRICA project aims to test a training platform directed to general practitioners (GPs) based in Lyon with the aim of improving their level of knowledge and skills in the field of primary prevention. The pilot phase of this project focuses on the topic of HPV vaccination.
Methodology:	The PAPRICA project is a randomized study. A face-to-face training workshop on HPV vaccination was offered to GPs based in Lyon, included in the intervention arm in 2017 and 2018. A questionnaire completed by GPs in pre- and post-intervention training (+ 18 days) evaluated changes (or not) of knowledge, attitudes, norms and prescription behaviours of these GPs about HPV vaccination. A digital and remote format will soon be available to GPs based in the Auvergne Rhône-Alpes in 2020.
Funding:	National Cancer Institute, France

Study sites:	Harare, Zimbabwe
Principal investigator (PI) from IARC:	P. Basu and C. Sauvaget
PIs from collaborating institutions:	Dr Bothwell T Guzha, University of Zimbabwe
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Start date:	2021
Closure date:	Ongoing
Objectives:	To study the feasibility, acceptability, safety, clinical utility and effectiveness of thermal ablation in cervical intraepithelial neoplasia (CIN) treatment To compare the intensity of pain during thermal ablation after application of local anaesthesia by lidocaine spray vs no lidocaine use To compare the cure rates of lesions treated by thermal ablation with two different durations of treatment: 20 seconds and 30 seconds
Methodology:	Randomized controlled trial with 4 groups: Thermal ablation for 30 seconds without lignocaine use Thermal ablation for 20 seconds without lignocaine use Thermal ablation for 30 seconds with lignocaine use Thermal ablation for 20 seconds with lignocaine use Thermal ablation will be provided to women referred for histology confirmed CIN 2 and CIN3 or to those presenting colposcopic impression of high grade cervical lesions. All lesions should be eligible to ablative treatment. Immediately after treatment, women will be inquired about the level of pain and the degree of satisfaction of the treatment. They will be invited at a 6-week, and a 12-month follow-up visits to report any adverse events and to measure the cure rate.
ClinicalTrials.gov identifier:	NCT02956239
Funding:	Intramural funds from IARC

Study sites:	Sikkim State, India
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Dr Phumzay Denzongpa, Health & Family Welfare Department - Government of Sikkim, India Dr Yogesh Verma, Sikkim Manipal Institute, Sikkim, India
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Start date:	2020
Closure date:	Ongoing
Objectives:	This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine. To estimate the prevalence of HPV infection based on cervical samples, among the married women aged 18 to 22 years at baseline (in the year 2020-21) and seven years after the initiation of the HPV vaccination program (in the year 2025-26) To estimate the type-specific prevalence of HPV-DNA based on cervical samples, among the married women aged 18 to 22 years at baseline (in the year 2020-21) and seven years after the initiation of HPV vaccination program (in the year 2025-26) To estimate the overall effectiveness of two-dose multi-age cohort HPV vaccination in preventing cervical HPV infection among the women aged 18 to 22 years To estimate the prevalence of chlamydia trachomatis infection of the genital tract at baseline and in the year 2025-26 (this will allow us to detect any change in the background risk of sexually transmitted infections)
Methodology:	The participants (N=2,750) will be recruited from the gynecology out-patients department of Sikkim Manipal Hospital and STNM Hospital and the four district hospitals. While Sikkim Manipal and STNM Hospitals are situated in the capital city of Gangtok, there is one district hospital in each of the four districts (east, west, north and south). The targeted number of women to be recruited from each hospital during the baseline and the repeat surveys will be proportionate to the population of the catchment district. The participants will be recruited to ensure that they are equally distributed among two age ranges – 18-20 years and 21-22 years. The women in the target age group attending the gynecology department for various reasons (including antenatal checkups) will be approached. They will be counseled and a written informed consent will be obtained from them prior to recruitment to the study. The socio-demographic information, sexual history and HPV vaccination history will be obtained.
Funding:	Intramural funds from IARC

Study sites:	Lusaka, Zambia
Principal investigator (PI) from IARC:	P. Basu
PIs from collaborating institutions:	Julia Bohlius, Institute of Social and Preventive Medicine (ISPM), Bern, Switzerland Albert Manasyan, Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia
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Start date:	2017
Closure date:	Ongoing
Objectives:	HIV-infected women living in southern Africa have a far higher risk of developing invasive cervical cancer than do HIV-uninfected women. Visual inspection with acetic acid (VIA) is the simplest method of screening for cervical intraepithelial neoplasia (CIN), and WHO recommends this method when no other options are available. However, the test accuracy of VIA is inferior to the accuracy of other methods. The optimal screening strategy (or combination of strategies) in low- and middle-income countries (LMICs) remains unclear. WHO has acknowledged the urgent need to improve screening strategies in LMICs, and especially among HIV-infected women. The evaluation of alternative screening strategies using stand-alone tests or combinations of tests may identify screening strategies with higher test accuracy in HIV-infected women that are feasible in LMICs in southern Africa and elsewhere. This study will evaluate a low-cost portable magnifying device (the Gynocular), with the following objectives: to estimate the sensitivity and specificity of the Gynocular when used in addition to VIA (i.e. as an add-on test) in detecting CIN 2+ in HIV-infected women, to compare the sensitivity and specificity levels of the Gynocular as an add-on test to those of VIA alone, and to determine the optimal cut-off points for the Swede score to identify CIN 2+ lesions in HIV-infected women.
Methodology:	The study will be a prospective clinical trial with 350 participants: HIV-infected women receiving care at the Chelstone Clinic in Lusaka, Zambia. The primary analysis will be of the performance of the Gynocular mobile colposcope compared with that of the current standard of care: VIA. Secondary analyses will be performed to investigate various combinations of screening tests and to compare the use of the Gynocular with testing for high-risk (HR) HPV types. Baseline tests including blood tests to determine CD4 cell count and HIV RNA viral load will be performed for all participants, and vaginal swabs will be collected to test for Trichomonas vaginalis, Chlamydia trachomatis, and Neisseria gonorrhoeae infection using the GeneXpert system (TCG testing). All consenting study participants will undergo HR-HPV testing, VIA screening, and Gynocular assessment, in that sequence. Different assessors will perform the VIA and Gynocular examinations to maintain blinding. All participants will undergo biopsy during their first study visit. VIA-positive women and women with CIN 1+ will receive treatment per the national guidelines. For VIA-positive women, treatment will be provided during the same visit, following screening. Women found to require treatment after a positive biopsy will receive it during the planned 2-week follow-up visit. All women enrolled in the study will be invited for follow-up at 6 months after the initial screening. This measure is designed to reduce misclassification bias, and mitigates the limitations of our reference test.
Funding:	Swiss Cancer Research

Study sites:	Madagascar, Malawi, Nigeria, Uganda, United Republic of Tanzania, Zambia
Principal investigator (PI) from IARC:	N. Broutet (WHO)
PIs from collaborating institutions:	Sonia Andrianabela, Ministry of Health, Madagascar Frank Taulo, College of Medicine, Malawi Peter Adefuye, Olabisi Onabanjo University Teaching Hospital, Nigeria Daniel Murokoro, Uganda Women’s Health Initiative, Kampala, Uganda Gonzaga Gonza Ssenyondo, Masaka General Hospital, Uganda Gaudence Komba, Peramiho Hospital, United Republic of Tanzania Olola Oneko, Kilimanjaro Christian Medical Centre, United Republic of Tanzania Gricelia Mkumba, University Teaching Hospital, Zambia
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Start date:	2005
Closure date:	2009
Objectives:	To create awareness about cervical cancer, its effects, and the availability of prevention services To assess the acceptability of cervical cancer screening using VIA and the treatment of precancerous lesions by cryotherapy among the target population, health-care providers, and health officials (i.e. the women, their community, health-care workers, policy makers, and programme managers) To assess the feasibility and efficiency (in terms of running costs, personnel, training, and equipment) for the single-visit approach in the prevention of cervical cancer
Methodology:	The overall strategy of this project was to create awareness in the communities about cervical cancer prevention through information, education, and communication (IEC); to recruit participants; to provide screening by VIA; and to treat eligible participants by cryotherapy and refer non-eligible participants for further evaluation and treatment. Additionally, continuous monitoring and evaluation of the project was carried out in order to generate evidence about the acceptability and feasibility of such a project in a district and/or a primary health-care centre. View report
Publications:	Simms K.T., Keane A., Nguyen D.T.N., Caruana M., Hall M.T., Lui G., Gauvreau C., Demke O., Arbyn M., Basu P., Wentzensen N., Lauby-Secretan B., Ilbawi A., Hutubessy R., Almonte M., De Sanjosé S., Kelly H., Dalal S., Eckert L.O., Santesso N., Broutet N., Canfell K. Benefits, harms and cost-effectiveness of cervical screening, triage and treatment strategies for women in the general population. Nat Med. 2023 Dec;29(12):3050-3058. doi: 10.1038/s41591-023-02600-4. PMID: 38087115 African Population and Health Research Center, International Agency for Research on Cancer, World Health Organization. Prevention of cervical cancer through screening using visual inspection with acetic acid (VIA) and treatment with cryotherapy: a demonstration project in six African countries: Malawi, Madagascar, Nigeria, Uganda, the United Republic of Tanzania, and Zambia. Geneva: World Health Organization; 2012. View report
Funding:	WHO

Study sites:	Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh Instituto de Prevenção do Câncer do Colo do Útero, Porto Alegre, Brazil Christian Fellowship Community Health Centre, Ambilikkai, India Nargis Dutt Memorial Cancer Hospital, Barshi, India Jehangir Clinical Development Centre, Pune, India Regional Cancer Centre, Thiruvananthapuram, India
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Ashrafun Nessa, BSMMU, Bangladesh Paulo Naud, Instituto de Prevenção do Câncer do Colo do Útero, Porto Alegre, Brazil Pulikattil Okkaru Esmy, Christian Fellowship Community Health Centre, Ambilikkai, India Bhagwan M. Nene, Nargis Dutt Memorial Cancer Hospital, Barshi, India Smita Joshi, Jehangir Clinical Development Centre, Pune, India Ramani Wesley, Regional Cancer Centre, Thiruvananthapuram, India
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Start date:	2009
Closure date:	2015
Objectives:	To study the feasibility, acceptability, safety, clinical utility, and effectiveness of cold coagulation treatment in the prevention of cervical intraepithelial neoplasia (CIN) in health-care settings with no capacity for colposcopy, directed biopsy, or histological evaluation of lesions
Methodology:	Data are obtained for women treated for CIN 2–3 lesions by thermocoagulation and followed-up after 1 year. The proportions of women with no evidence of disease, adverse effects, or complications are determined.
Publications:	Naud P. S., Muwonge R., Passos E. P., Magno V., Matos J., Sankaranarayanan R. Efficacy, safety, and acceptability of thermocoagulation for treatment of cervical intraepithelial neoplasia in a hospital setting in Brazil. Int J Gynaecol Obstet. 2016;133(3):351-4. PMID: 27005927 Dolman L., Sauvaget C., Muwonge R., Sankaranarayanan R.. Meta-analysis of the efficacy of cold coagulation as a treatment method for cervical intraepithelial neoplasia: a systematic review. BJOG. 2014;121(8):929-42. PMID: 24597779 Randall T.C., Sauvaget C., Muwonge R., Trimble E.L., Jeronimo J. Worthy of further consideration: An updated meta-analysis to address the feasibility, acceptability, safety and efficacy of thermal ablation in the treatment of cervical cancer precursor lesions. Prev Med. 2018 Oct 17;118:81-91. PMID: 30342109 Randall T.C., Sauvaget C., Muwonge R., Trimble E.L., Jeronimo J. Authors response to Papoutsis and colleagues letter to the editor regarding: Worthy of further consideration: An updated meta-analysis to address the feasibility, acceptability, safety and efficacy of thermal ablation in the treatment of cervical cancer precursor lesions. Prev Med. 2019 Feb 10. PMID: 30759368
Funding:	IARC

Study sites:	Pune, India
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Smita Joshi, Jehangir Clinical Development Centre, Pune, India
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Start date:	2010
Closure date:	2011
Objectives:	To evaluate an accurate, affordable, and feasible method to screen and treat HIV-infected women
Methodology:	A cross-sectional study was conducted in India in which eligible HIV-infected women underwent visual inspection with acetic acid (VIA), visual inspection with Lugol’s iodine (VILI), cytology, human papillomavirus (HPV) testing, and colposcopy. All screened women had colposcopy, and women with colposcopic abnormalities had directed biopsies. Women with suspected cervical intraepithelial neoplasia (CIN) on colposcopy were treated with thermocoagulation or the loop electrosurgical excision procedure. Sensitivity, specificity, and predictive values of the screening tests were calculated.
Publications:	Joshi S., Kulkarni V., Gangakhedkar R., Sankaranarayanan R. Are we missing opportunities to prevent cervical cancer in HIV-infected women in India? Indian J Med Res. 2015;142(5):610-3. PMID: 26658598 Joshi S., Sankaranarayanan R., Muwonge R., Kulkarni V., Somanathan T., Divate U. Screening of cervical neoplasia in HIV-infected women in India. AIDS. 2013;27(4):607-15. PMID: 23079814 Joshi S., Muwonge R., Kulkarni V., Deodhar K., Mandolkar M., Lucas E., Sankaranarayanan R. Incidence of cervical intraepithelial neoplasia in women infected with human immunodeficiency virus (HIV) with no evidence of disease at baseline: results of a prospective cohort study with up to 6.4 years of follow-up from India. Int J Cancer. 2018 Aug 22. PMID: 30132840
Funding:	UICC European Union

Study sites:	Ubon Ratchathani, Thailand
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Suleeporn Sangrajrang, Piyawat Laowahutanont, and Weerawut Imsamran; National Cancer Institute, Bangkok, Thailand Metee Wongsena, Ubon Ratchathani Cancer Hospital, Ubon Ratchathani, Thailand Virginia Senkomago, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, Atlanta, USA
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Start date:	2014
Closure date:	2015
Objectives:	This cross-sectional study of the test performance, feasibility, and acceptability of HPV testing in Thailand’s Ubon Rachathani province was prompted by several key factors: the causal role of persistent high-risk HPV (hr-HPV) infection in cervical carcinogenesis, the high level of accuracy of HPV testing in detecting cervical neoplasia, the recent development of assays that enable the detection of hr-HPV DNA in cervical specimens, the high negative predictive value of negative HPV tests for cervical intraepithelial neoplasia (CIN) grade 2 or worse lesions, and the potential value of HPV testing as an objective screening test in the post–HPV vaccination era. The findings from the study will help to guide the eventual scaling up of HPV testing as a primary screening test nationwide. The study evaluated the potential for using hr-HPV testing–based screening for CIN in routine health services in Thailand, its accuracy in comparison with that of conventional cytology, and the utility of HPV16/18-positive results and liquid-based cytology triage for HPV-positive women in the detection of high-grade CIN.
Methodology:	The eligible population was apparently healthy women aged 30–60 years, served by 50 primary health care units in 7 districts of Ubon Ratchathani province in northern Thailand in the context of the national cervical cytology screening programme. Participants were recruited during the period from July 2014 to January 2015 and screened with both conventional cytology and hr-HPV testing using the cobas 4800 System (Roche Molecular Systems Inc., Branchburg (NJ), USA). Women who tested positive by either method were referred for colposcopy and/or directed biopsies. In cases of normal colposcopic findings, cervical biopsies were randomly obtained. The final diagnosis was based on histology, or on colposcopy when histology was not available. Test accuracy parameters were estimated with latent class analysis using Bayesian models.
Publications:	Sangrajrang S., Laowahutanont P., Wongsena M., Muwonge R., Karalak A., Imsamran W., Senkomago V., Sankaranarayanan R. Comparative accuracy of Pap smear and HPV screening in Ubon Ratchathani in Thailand. Papillomavirus Res; 2017; 30-35. PMID: 28720454
Funding:	The Government of Thailand

Study sites:	India: Ahmedabad, Ambilikkai, Barshi, Hyderabad, Kolkata, Mizoram, Mumbai, New Delhi, Pune, Sikkim, Thiruvananthapuram
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Parimal J. Jivarajani, Geeta Joshi, Gujarat Cancer & Research Institute (GCRI), Ahmedabad Pulikattil Okkaru Esmy, Christian Fellowship Community Health Centre (CFCHC), Ambilikkai S. Malvi, Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi P. Usha Rani Reddy Poli, Mehdi Nawaj Jung Cancer Institute (MNJCI), Hyderabad Maqsood Siddiqi, Cancer Foundation of India (CFI), Kolkata Eric Zomawia, Civil Hospital, Aizawl, Mizoram S. Shastri, Sharmila Pimple, Tata Memorial Centre (TMC), Mumbai Neerja Bhatla, All India Institute of Medical Science (AIIMS), New Delhi Smita Joshi, Jehangir Clinical Development Centre (JCDC), Pune Yogesh Verma, Sir Thodup Namgyal Memorial Hospital (STNM), Gangtok, Sikkim M. Radhakrishna Pillai, Rajiv Gandhi Centre for Biotechnology (RGCB), Thiruvananthapuram
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Start date:	2009
Closure date:	2012
Objectives:	To generate evidence on the efficacy of two doses compared with three doses of HPV vaccination To generate information on the feasibility, safety, and acceptability of two-dose vaccination regimens To provide decision-makers with operational, efficacy, and safety data To disseminate the information about the feasibility, effectiveness, safety, and acceptability of the vaccination approaches
Methodology:
ClinicalTrials.gov identifier:	NCT00923702
Study outcomes:	The study recruited 17 729 girls/women into the two- and three-dose groups. The results demonstrated that two doses of the HPV vaccine (administered at a 6-month interval) were as immunogenic as three doses in girls less than 15 years of age. This evidence was used by the WHO to support their two-dose recommendation for girls aged less than 15 years.
Publications:	Sankaranarayanan R., Prabhu P. R., Pawlita M., Gheit T., Bhatla N., Muwonge R., Nene B. M., Esmy P. O., Joshi S., Poli U. R., Jivarajani P., Verma Y., Zomawia E., Siddiqi M., Shastri S. S., Jayant K., Malvi S. G., Lucas E., Michel A., Butt J., Vijayamma J. M., Sankaran S., Kannan T. P., Varghese R., Divate U., Thomas S., Joshi G., Willhauck-Fleckenstein M., Waterboer T., Muller M., Sehr P., Hingmire S., Kriplani A., Mishra G., Pimple S., Jadhav R., Sauvaget C., Tommasino M., Pillai M. R. Immunogenicity and HPV infection after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre prospective cohort study. Lancet Oncol. 2016;17(1):67-77. PMID: 26652797
Funding:	Bill & Melinda Gates Foundation Merck (through their donation of Gardasil® vaccines)
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Study sites:	Barshi, Osmanabad District, India
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Bhagwan M. Nene, Sylla Malvi, Kasturi Jayant, Madan Chauhan, Sanjay Hingmire, Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi, Osmanabad District, India K.A. Dinshaw, Surendra Shastri, Tata Memorial Centre (TMC), Mumbai, India
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Start date:	1999
Closure date:	2015
Objectives:	Primary objectives To evaluate the reduction in cervical cancer incidence and mortality associated with a single round of screening with visual inspection with acetic acid (VIA), cytology, or HPV DNA testing compared with the usual care To evaluate the cost-effectiveness of the above three screening approaches Other objectives To identify the factors affecting participation in screening/diagnosis/treatment To determine the safety and effectiveness of cryotherapy performed by nurses To determine the safety and effectiveness of the loop electrosurgical excision procedure (LEEP) performed by mid-level clinicians To investigate overtreatment associated with basing treatment decisions on colposcopy
Methodology:
Study outcomes:	Eligible women (aged 30–59 years, N = 160 000) living in 502 villages served by 52 primary health centres in the district were randomized (per primary health centre) to receive either VIA, conventional cytology, or HPV DNA testing for cervical cancer screening, or to the control group. This study was the first to demonstrate a significant reduction in mortality due to cervical cancer after even a single round of HPV screening and appropriate management of the screen-positive participants. The evidence from this randomized controlled trial has been used extensively by international and national organizations to support recommendations for HPV testing as primary screening for cervical cancer.
Publications:	Jayant K., Sankaranarayanan R., Thorat R. V., Muwonge R., Hingmire S. J., Panse N. S., Shastri S. S., Malvi S. G., Nene B. Improved Survival of Cervical Cancer Patients in a Screened Population in Rural India. Asian Pac J Cancer Prev. 2016;17(11):4837-44. PMID: 28030908 Sankaranarayanan R., Nene B.M., Dinshaw K.A., Mahe C., Jayant K., Shastri S.S., Malvi S.G., Chinoy R., Kelkar R., Budukh A.M., Keskar V., Rajeshwarker R., Muwonge R., Kane S., Parkin D.M., Chauhan M.K., Desai S., Fontaniere B., Frappart L., Kothari A., Lucas E., Panse N.; Osmanabad District Cervical Screening Study Group. A cluster randomized controlled trial of visual, cytology and human papillomavirus screening for cancer of the cervix in rural India. Int J Cancer. 2005;116(4):617-23. PMID: 15818610 Legood R., Gray A.M., Mahé C., Wolstenholme J., Jayant K., Nene B.M., Shastri S., Malvi S.G., Muwonge R., Budukh A.M., Sankaranarayanan R. Screening for cervical cancer in India: How much will it cost? A trial based analysis of the cost per case detected. Int J Cancer. 2005;117(6):981-7. PMID: 16003735 Nene B., Jayant K., Arrossi S., Shastri S., Budukh A., Hingsmire S., Muwonge R., Malvi S., Dinshaw K., Sankaranarayanan R. Determinants of women’s participation in cervical cancer screening trial, Maharashtra, India. Bull World Health Organ. 2007;85(4):264-72. PMID: 17546307 Sankaranarayanan R., Nene B.M., Shastri S.S., Jayant K., Muwonge R., Budukh A.M., Hingmire S., Malvi S.G., Thorat R., Kothari A., Chinoy R., Kelkar R., Kane S., Desai S., Keskar V.R., Rajeshwarkar R., Panse N., Dinshaw K.A. HPV screening for cervical cancer in rural India. N Engl J Med. 2009;360(14):1385-94. PMID: 19339719 Muwonge R., Wesley R.S., Nene B.M., Shastri S.S., Jayant K., Malvi S.G., Thara S., Sankaranarayanan R. Evaluation of cytology and visual triage of human papillomavirus-positive women in cervical cancer prevention in India.Int J Cancer. 2014;134(12):2902-9. PMID: 24272364
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)
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Study sites:	Ambilikkai, Dindigul District, Tamil Nadu, India
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	R. Rajkumar, Pulikattil Okkaru Esmy, Christian Fellowship Community Health Centre (CFCHC), Ambilikkai, Dindigul District, Tamil Nadu, India
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Start date:	2000
Closure date:	2015
Objectives:	Primary objectives To evaluate the reduction in cervical cancer incidence and mortality associated with a single round of screening with visual inspection with acetic acid (VIA) compared with the usual care To evaluate the cost-effectiveness of VIA screening Secondary objectives To identify determinants of participation in screening/diagnosis/treatment To investigate overtreatment associated with basing treatment decisions on colposcopy To determine the safety and effectiveness of cryotherapy performed by nurses under field conditions To determine the safety and effectiveness of the loop electrosurgical excision procedure (LEEP) performed by mid-level clinicians
Methodology:
Study outcomes:	Eligible women (aged 30–59 years, N = 74 500) living in 133 village clusters in Dindigul District, Tamil Nadu, India, were randomized to either the intervention group or the control group. The study demonstrated a 35% reduction in mortality due to cervical cancer after a single round of VIA screening. The results have been widely used by various national and international organizations to support recommendations for VIA screening in resource-limited settings. The government of Tamil Nadu decided to scale up the project and initiated population-based cervical and breast cancer screening throughout the state.
Publications:	Thulaseedharan J.V., Malila N., Swaminathan R., Esmy P.O., Cherian M., Hakama M., Muwonge R., Sankaranarayanan R. Effect of Screening on Variation in Cervical Cancer Survival by Socioeconomic Determinants - a Study from Rural South India. Asian Pac J Cancer Prev. 2015;16(13):5237-42. PMID: 26225659 Swaminathan R., Selvakumaran R., Esmy P.O., Sampath P., Ferlay J., Jissa V., Shanta V., Cherian M., Sankaranarayanan R. Cancer pattern and survival in a rural district in South India. Cancer Epidemiol. 2009;33(5):325-31. PMID: 19853553 Sankaranarayanan R., Esmy P.O., Rajkumar R., Muwonge R., Swaminathan R., Shanthakumari S., Fayette J.M., Cherian J. Effect of visual screening on cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised trial. Lancet. 2007;370(9585):398-406. PMID: 17679017 Sankaranarayanan R., Rajkumar R., Theresa R., Esmy P.O., Mahé C., Bagyalakshmi K.R., Thara S., Frappart L., Lucas E., Muwonge R., Shanthakumari S., Jeevan D., Subbarao T.M., Parkin D.M., Cherian J. Initial results from a randomized trial of cervical visual screening in rural south India. Int J Cancer. 2004 Apr 10;109(3):461-7. PMID: 14961588 Sankaranarayanan R., Rajkumar R., Arrossi S., Theresa R., Esmy P.O., Mahé C., Muwonge R., Parkin D.M., Cherian J. Determinants of participation of women in a cervical cancer visual screening trial in rural south India. Cancer Detect Prev. 2003;27(6):457-65. PMID: 14642554 Thulaseedharan J.V., Malila N., Esmy P.O., Muwonge R., Hakama M., Sankaranarayanan R. Risk of invasive cancer among women visually screened and colposcopy triaged by trained nurses in rural South India. Int J Gynaecol Obstet. 2015;129(2):104-8. PMID: 25661324
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)
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Study sites:	Barshi, India
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Kedar Deodhar, Tata Memorial Centre (TMC), Mumbai, India Bhagwan M. Nene, Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi, India
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Start date:	2006
Closure date:	2007
Objectives:	Primary objective To produce affordable, less-expensive, accurate, user-friendly, and validated HPV tests by modifying or developing biochemical testing technology to develop two test formats (the rapid batch test format and the rapid strip test format) for ready use in low-resource settings Secondary objectives To evaluate the concurrent performance of other screening tests, such as cervical cytology, visual inspection with acetic acid (VIA), and visual inspection with Lugol’s iodine (VILI) in detecting cervical neoplasia To test the relative strengths of various risk factors for HPV infection and cervical neoplasia
Methodology:	The Indian component of the START project aimed to collect vaginal and cervical cell samples from women with histologically confirmed cervical intraepithelial neoplasia (CIN), as well as from a proportion of healthy women, in order to research, develop, verify, and validate these new tests in the field studies. Thus, the project involved obtaining vaginal and cervical specimens, screening women and treating those with high-grade cervical cancer precursor lesions and invasive cervical cancer, transferring a selection of biological samples to the Program for Appropriate Technology in Health (PATH), and validating and evaluating prototype tests.
Publications:	Deodhar K., Gheit T., Vaccarella S., Romao C.C., Tenet V., Nene B.M., Jayant K., Kelkar R., Malvi S.G., Sylla B.S., Franceschi S., Jeronimo J., Shastri S., Sankaranarayanan R., Tommasino M. Prevalence of human papillomavirus types in cervical lesions from women in rural Western India. J Med Virol. 2012;84(7):1054-60. PMID: 22585722 Deodhar K., Sankaranarayanan R., Jayant K., Jeronimo J., Thorat R., Hingmire S., Muwonge R., Chiwate A., Deshpande R., Ajit D., Kelkar R., Rekhi B., Ruben I., Malvi S.G., Chinoy R., Jambhekar N., Nene B.M. Accuracy of concurrent visual and cytology screening in detecting cervical cancer precursors in rural India. Int J Cancer. 2012;131(6):E954-62. PMID: 22581670
Funding:	Program for Appropriate Technology in Health (PATH), Seattle, USA
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Study sites:	Ouagadougou, Burkina Faso Brazzaville, Congo Conakry, Guinea Jaipur, Rajasthan, India Kolkata, India Mumbai, India Thiruvananthapuram, India Bamako, Mali Niamey, Niger
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Namory Keita, Service de Gynécologie/Obstétrique, Université de Conakry, Conakry, Guinea Amadou Dolo, Département de Gynécologie-Obstétrique, Hôpital Gabriel Touré, Bamako, Mali Charles Gombe Mbalawa, Département de Gynécologie, Université Marien Ngouabi, Brazzaville, Congo Hassan Nouhou, Faculté des Sciences de la Santé, Université de Niamey, Niamey, Niger Boblewende Sakande, Laboratoire de Biologie Médicale et d’Histo-Cyto-Pathologie, Clinique Philadelphie, Ouagadougou, Burkina Faso Ramani Wesley, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram, Kerala, India Thara Somanathan, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram, Kerala, India Anjali Sharma, Bhagwan Mahaveer Cancer Hospital & Research Centre (BMCHRC), Jaipur, Rajasthan, India Surendra Shastri, Preventive Oncology, Tata Memorial Hospital & Cancer Research Institute, Mumbai, India Partha Basu, Chittaranjan National Cancer Institute, Kolkata, India
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Start date:	1999
Closure date:	2004
Objectives:	To estimate the performance of visual inspection with acetic acid (VIA) and visual inspection with Lugol’s iodine (VILI) in detecting cervical intraepithelial neoplasia (CIN) To evaluate the see-and-treat approach in routine health-care settings for feasibility, safety, acceptability, and the extent of overtreatment
Methodology:
Study outcomes:	This major multicentre study demonstrated the test characteristics of VIA and VILI in low-resource settings. The study also helped to improve the capacity for screening, performing colposcopy, and treating cervical premalignant lesions in the large number of study sites.
Publications:	Muwonge R., Ngo Mbus L., Ngoma T., Gombe Mbalawa C., Dolo A., da Ganda Manuel M., Nouhou H., Nacoulma M., Mwaiselage J., Koulibaly M., Bayo S., Nsonde Malanda J., De Vuyst H., Herrero R., Sankaranarayanan R., Keita N. Socio-demographic and reproductive determinants of cervical neoplasia in seven sub-Sahara African countries. Cancer Causes Control. 2016;27(12):1437-46. PMID: 27822586 Teguete I., Muwonge R., Traore C.B., Dolo A., Bayo S., Sankaranarayanan R. Can visual cervical screening be sustained in routine health services? Experience from Mali, Africa. BJOG. 2012;119(2):220-6. PMID: 21895956 Arbyn M., Sankaranarayanan R., Muwonge R., Keita N., Dolo A., Mbalawa C.G., Nouhou H., Sakande B., Wesley R., Somanathan T., Sharma A., Shastri S., Basu P. Pooled analysis of the accuracy of five cervical cancer screening tests assessed in eleven studies in Africa and India. Int J Cancer. 2008;123(1):153-60. PMID: 18404671 Muwonge R., Mbalawa C.G., Keita N., Dolo A., Nouhou H., Nacoulma M., Malanda J.N., Koulibaly M., Bayo S., Sankaranarayanan R.; IARC Multicentre Study Group on Cervical Cancer Early Detection. Performance of colposcopy in five sub-Saharan African countries. BJOG. 2009;116(6):829-37. PMID: 19432573
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)
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Study sites:	Luanda, Angola
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Miraldina da Ganda Manuel, Clinica da Rainha Ginga, Consultorio Médico, Médica Especialista Ginecologia Obstetricia, Luanda, Angola
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Start date:	2002
Closure date:	2006
Objectives:	To evaluate the feasibility of cervical screening using visual inspection with acetic acid (VIA) or with Lugol’s iodine (VILI) to detect and treat cervical intraepithelial neoplasia (CIN)
Methodology:	All 8851 women screened by trained nurses received visual inspection followed by colposcopy and/or colposcopically directed biopsy. When no or inadequate biopsies were performed, final disease status was determined on the basis of histopathology or colposcopy. The sensitivity, specificity, and predictive values of the two visual tests to detect CIN 2–3 were calculated.
Study outcomes:	The study added to the evidence base supporting the use of visual screening tests in low- and middle-income countries.
Publications:	Muwonge R., Manuel Mda G., Filipe A.P., Dumas J.B., Frank M.R., Sankaranarayanan R. Visual screening for early detection of cervical neoplasia in Angola. Int J Gynaecol Obstet. 2010;111(1):68-72. PMID: 20570259
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)

Study sites:	India: Ambilikkai, Barshi, Mumbai, Thiruvananthapuram
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	R. Rajkumar, P.O. Esmy, Christian Fellowship Community Health Centre, Ambilikkai, Dindigul District, Tamil Nadu S. Thara, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram Bhagwan M. Nene, Nargis Dutt Memorial Cancer Hospital, Tata Memorial Centre Rural Cancer Extension Project, Barshi, Solapur District, Maharashtra Surendra S. Shastri, Tata Memorial Centre, Mumbai, Maharashtra Prabhakaran Rema, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram Ramani Wesley, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram
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Start date:	2006
Closure date:	2009
Objectives:	To assess the effectiveness, safety, and acceptability of treatment of cervical intraepithelial neoplasia (CIN) with cryotherapy provided by midwives and with the loop electrosurgical excision procedure (LEEP) performed by newly trained physicians
Methodology:	Women with colposcopic findings of CIN lesions suitable for ablative treatment received cryotherapy from trained midwives before the biopsy results were known. Women with CIN colposcopic features unsuitable for cryotherapy were treated with LEEP using a see-and-treat approach. Women with unsatisfactory colposcopy had diagnostic LEEP. Cure was defined as no clinical or histological evidence of CIN at follow-up after 1 year.
Study outcomes:	The study demonstrated the safety and efficacy of treating premalignant lesions using cryotherapy administered by trained nurses. The cure rate of high-grade lesions with cryotherapy was about 70%. The complication rates of cryotherapy were very low.
Publications:	Sankaranarayanan R., Rajkumar R., Esmy P.O., Fayette J.M., Shanthakumary S., Frappart L., Thara S., Cherian J. Effectiveness, safety and acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening study in India. Br J Cancer. 2007;96(5):738-43. PMID: 17311015 Nene B.M., Hiremath P.S., Kane S., Fayette J.M., Shastri S.S., Sankaranarayanan R. Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical intraepithelial neoplasia in Maharashtra, India. Int J Gynaecol Obstet. 2008;103(3):232-6. PMID: 18817909 Rema P., Suchetha S., Thara S., Fayette J.M., Wesley R., Sankaranarayanan R. Effectiveness and safety of loop electrosurgical excision procedure in a low-resource setting. Int J Gynaecol Obstet. 2008;103(2):105-10. PMID: 18760779 Sankaranarayanan R., Keshkar V., Kothari A., Kane S., Fayette J.M., Shastri S. Effectiveness and safety of loop electrosurgical excision procedure for cervical neoplasia in rural India. Int J Gynecol Obstet. 2009;104(2):95-9. PMID: 18962583
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)

Study sites:	Dar es Salaam, United Republic of Tanzania
Principal investigator (PI) from IARC:	R. Sankaranarayanan
PIs from collaborating institutions:	Twalib Ngoma, Ocean Road Cancer Institute, Dar es Salaam, United Republic of Tanzania
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Start date:	2003
Closure date:	2007
Objectives:	To evaluate the feasibility and performance of screening for cervical cancer using visual inspection with acetic acid (VIA) or with Lugol’s iodine (VILI) in Dar es Salaam, United Republic of Tanzania
Methodology:	The accuracy of tests for detecting cervical intraepithelial neoplasia (CIN) was assessed in a cross-sectional study of 10 378 women. All women who were screened underwent colposcopy, and biopsies were offered to those with abnormal colposcopy results.
Study outcomes:	The results added to the evidence base supporting VIA and VILI screening in low- and middle-income countries.
Publications:	Ngoma T., Muwonge R., Mwaiselage J., Kawegere J., Bukori P., Sankaranarayanan R. Evaluation of cervical visual inspection screening in Dar es Salaam, Tanzania. Int J Gynaecol Obstet. 2010;109(2):100-4. PMID: 20152973 Muwonge R., Ngo Mbus L., Ngoma T., Gombe Mbalawa C., Dolo A., da Ganda Manuel M., Nouhou H., Nacoulma M., Mwaiselage J., Koulibaly M., Bayo S., Nsonde Malanda J., De Vuyst H., Herrero R., Sankaranarayanan R., Keita N. Socio-demographic and reproductive determinants of cervical neoplasia in seven sub-Sahara African countries. Cancer Causes Control. 2016;27(12):1437-46. PMID: 27822586
Funding:	Bill & Melinda Gates Foundation through the Alliance for Cervical Cancer Prevention (ACCP)
Media:

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