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Cervical cancer



Study sites: India: Ahmedabad, Aizawl, Ambilikkai, Barshi, Hyderabad, Kolkata, Mumbai, New Delhi, Pune, Sikkim, Thiruvananthapuram
Principal investigator (PI) from IARC: R. Sankaranarayanan
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
Map:
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
Funding: Bill & Melinda Gates Foundation
Study sites: Lusaka, Zambia
Principal investigator (PI) from IARC: R. Sankaranarayanan
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
Map:
Start date: 2016
Closure date:Ongoing
Objectives:
  1. 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
  2. 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
Funding: United States National Institutes of Health (NIH)
Study sites:
  • Centre for Epidemiology and Prevention in Oncology (CPO), Italy
  • Cancer Society of Finland (CSF), Mass Screening Registry, Finland
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:
  • Antonio Ponti, Carlo Senore, Guglielmo Ronco, Nereo Segnan, CPO, Italy
  • Ahti Antilla, CSF, Mass Screening Registry, Finland
  • Representatives from EU Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Map:
Start date: 2015
Closure date:2017
Objectives:
  • To update and expand the scope of the first report
  • To report the updated status and organization of the population-based breast, cervical, and colorectal cancer screening programmes in the 28 EU Member States
  • To estimate selected indicators on programme performance included in the EU quality assurance guidelines for breast, cervical, and colorectal cancer screening
Methodology:
  • More than 100 experts from the 28 Member States contributed to the preparation of the report.
  • Qualitative data (nature and organization of the programme, protocol of screening and diagnosis, mode of invitation and recall, quality assurance practices, etc.) were collected through online questionnaires completed by the country data providers. The data providers were requested to provide the most up-to-date information as of July 2016.
  • Performance data (screening rate, coverage by invitation/examination, participation rate, and other indicators) were collected for the index year 2013 for countries having population-based programmes using structured data tables. The completeness of data collection across the screening and diagnosis processes was estimated.
  • Analysed data and the draft report were shared with the data providers and the scientific committee for review and validation.
Publications: View the report
Funding: The European Union Public Health Programme (scientific and technical support to the European Partnership for Action Against Cancer)
Study sites: Udaipur, India
Principal investigator (PI) from IARC: P. Basu
PIs from collaborating institutions:Manoj Mahajan (PI), Kirti Jain, Nilesh Patira, GBH Memorial Cancer Hospital, Udaipur, India
Map:
Start date: 2017
Closure date:Ongoing
Objectives: To evaluate the feasibility and acceptability of the model of delivering community health worker (CHW)–driven home-based comprehensive noncommunicable disease (NCD) control services aimed to prevent premature deaths from cardiovascular diseases; stroke; and breast, cervical, and oral cancers in hard-to-reach men and women
Methodology:
The implementation research has two main components, which will be conducted simultaneously:
  1. Evaluation of the social, cultural, and behavioural factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology
  2. Evaluation of the feasibility and acceptability of delivery of the NCD early detection services by the trained community health workers in home settings
Participants will be screened for hypertension, diabetes, oral cancer (for habitual users of tobacco products and/or consumers of alcoholic beverages), and cervical cancer (for women only, by HPV testing on self-collected specimens). Women will be made aware of common symptoms and signs of breast cancer. All services will be provided at home. The screen-positive men and women will be navigated to reach appropriate diagnostic and treatment centres.
Funding: American International Health Management Ltd
Study sites: Morocco: Casablanca, Fez, Rabat
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:
  • Professor Errihani, Medical School, Mohammed V University, Rabat
  • Dr Bendahhou, Cancer Centre Mohammed VI, Casablanca
  • Professor El Rhazi, National Institute of Research on Cancer, Fez
Map:
Start date: 2016
Closure date:Ongoing
Objectives: To evaluate the quality of care for women diagnosed with breast and cervical cancer within the public health delivery system of Morocco
Methodology:The basis of the study is a questionnaire survey based on medical charts. The key information that will be obtained from this retrospective study includes information regarding the mode of diagnosis, the gap between the onset of symptoms and diagnosis, the waiting time for start of treatment, and the factors influencing delays in diagnosis and initiation of treatment. The study will also gather information on the protocol followed for the diagnosis and treatment of breast and cervical cancers in the leading oncology centres in Morocco, and on the patients’ adherence to such protocols. Information on the quality of recordkeeping in the institutions will also be gathered from the study.
Funding:
  • Lalla Salma Foundation for Cancer Prevention and Treatment
  • IARC
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
Map:
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: 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: Pune, India
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:Smita Joshi, Jehangir Clinical Development Centre, Pune, India
Map:
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
Funding:
  • UICC
  • European Union
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
Map:
Start date: 2009
Closure date:Ongoing
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
Funding: IARC
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
Map:
Start date: 2009
Closure date:2012
Objectives:
  1. To generate evidence on the efficacy of two doses compared with three doses of HPV vaccination
  2. To generate information on the feasibility, safety, and acceptability of two-dose vaccination regimens
  3. To provide decision-makers with operational, efficacy, and safety data
  4. 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)
Media:
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
Map:
Start date: 1999
Closure date:Ongoing
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)
Media:
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
Map:
Start date: 2000
Closure date:Ongoing
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)
Media:
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
Map:
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
Media:
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
Map:
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)
Media:
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
Map:
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
Map:
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
Map:
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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