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Breast cancer early detection



Study sites: Thiruvananthapuram (formerly called Trivandrum), Kerala, India
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:K. Ramadas (PI), S. Thara, Beela Sarah Mathew, Elizabeth Abraham, Gigi Thomas, Jem Prabhakar, Paul Augustine, Ramani Wesley, R. Rejnish Kumar; Regional Cancer Centre (RCC), Thiruvananthapuram, Kerala, India
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Start date: 2006
Closure date:Ongoing
Objectives: To evaluate whether three rounds of triennial clinical breast examination (CBE) can reduce the incidence rate of advanced breast cancers and reduce the rate of mortality from breast cancer
Methodology:
Study outcomes: This community-based cluster randomized controlled trial involving 120 000 women evaluates the role of intervention packages consisting of breast awareness, health education, opportunities for early clinical diagnosis (i.e. CBE), and the provision of readily accessible diagnosis and treatment services for the early detection and improved outcome of breast cancer. The intervention trial is being conducted in 14 administrative regions (“panchayats”) in Thiruvananthapuram District, Kerala, India. Approximately 120 000 households and about 120 000 women aged 30–69 years in the two sub-districts were grouped into about 275 clusters based on wards; 133 clusters were randomized to the intervention group to receive CBE. The other 142 clusters were randomized to the control group to receive the existing usual health care and health education on early detection of breast cancer. We have already demonstrated significant downstaging of breast cancers through CBE screening. The 10-year follow-up of the cohorts revealed the high negative predictive value of CBE: the invasive breast cancer detection rate in the CBE-negative women was very low.
Publications: Search in Medline for Sankaranarayanan R., Ramadas K., Thara S., Muwonge R., Prabhakar J., Augustine P., Venugopal M., Anju G., Mathew B.S. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011;103(19):1476-80.Sankaranarayanan R., Ramadas K., Thara S., Muwonge R., Prabhakar J., Augustine P., Venugopal M., Anju G., Mathew B.S. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011;103(19):1476-80.
PMID: 21862730
Search in Medline for Grosse Frie K., Ramadas K., Anju G.A., Mathew B., Muwonge R., Sauvaget C., Thara S., Sankaranarayanan R. Determinants of participation in a breast cancer screening trial in Trivandrum District, India. Asian Pac J Cancer Prev. 2013;14(12):7301-7.Grosse Frie K., Ramadas K., Anju G.A., Mathew B., Muwonge R., Sauvaget C., Thara S., Sankaranarayanan R. Determinants of participation in a breast cancer screening trial in Trivandrum District, India. Asian Pac J Cancer Prev. 2013;14(12):7301-7.
PMID: 24460292
Funding: Intramural funds from IARC
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Study sites: Lyon, France
Principal investigator (PI) from IARC: P. Villain
PIs from collaborating institutions:
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Start date: 2019
Closure date:Ongoing
Objectives: Based on the Action Plan for the renovation of organized breast cancer screening provided par INCa, the project aims to create a free and private social network open only to women receiving a letter of invitation to participate in the organized screening program for breast cancer. This network will be a decision-making tool for women and also a tool to help the "shared medical decision" about screening as it will provide for participation of health care providers.
Methodology:In order to develop this network (content and functionality), two expert committees (national and international) will be set up, including representatives of public health, health professionals (generalists, gynaecologists, nurses), breast cancer screening specialists and representatives of patient organizations. The international committee, by supporting a systematic review of the scientific literature, will be responsible for producing recommendations and specifications for development (content - decision support, tools to help with "shared medical decision" and scales/tools evaluation - and functionality) of this network.
Funding: National Cancer Institute, France
Study sites: China: Shanxi Province, Sichuan Province
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:Youlin Qiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS)
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Start date: 2011
Closure date:Ongoing
Objectives: To test whether the transillumination breast device is effective in detecting breast lumps and early breast cancers in a chosen setting
Methodology:This is a hospital-based cross-sectional study including women aged 35–69 years referred to two provincial hospitals for breast complaints needing further investigation. All women receive clinical breast examination, TBS, mammography, and echography if needed. The performance of TBS is compared with that of clinical breast examination (CBE) screening and of mammography screening; histology results are used as the gold standard.
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
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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.
Publications: Search in Medline for Basu P., Selmouni F., Belakhel L., Sauvaget C., Abousselham L., Lucas E., Muwonge R., Sankaranarayanan R., Khazraji Y.C. Breast Cancer Screening Program in Morocco: Status of implementation, organization and performance. Int J Cancer. 2018 Jul 14.Basu P., Selmouni F., Belakhel L., Sauvaget C., Abousselham L., Lucas E., Muwonge R., Sankaranarayanan R., Khazraji Y.C. Breast Cancer Screening Program in Morocco: Status of implementation, organization and performance. Int J Cancer. 2018 Jul 14.
PMID: 30006933
Search in Medline for Selmouni F., Zidouh A., Belakhel L., Sauvaget C., Bennani M., Khazraji Y.C., Benider A., Wild C.P., Bekkali R., Fadhil I., Sankaranarayanan R. Tackling cancer burden in low-income and middle-income countries: Morocco as an exemplar. Lancet Oncol. 2018 Feb;19(2):e93-e101.Selmouni F., Zidouh A., Belakhel L., Sauvaget C., Bennani M., Khazraji Y.C., Benider A., Wild C.P., Bekkali R., Fadhil I., Sankaranarayanan R. Tackling cancer burden in low-income and middle-income countries: Morocco as an exemplar. Lancet Oncol. 2018 Feb;19(2):e93-e101.
PMID: 29413484
Funding:
  • Lalla Salma Foundation for Cancer Prevention and Treatment
  • IARC
Study sites: Rabat and Casablanca, Morocco
Principal investigator (PI) from IARC: P. Basu
PIs from collaborating institutions:Dr Karima Bendahhou
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Start date: 2019
Closure date:Ongoing
Objectives: To compare the breast cancer cases diagnosed through the program (participants) and those diagnosed outside the program (comparison group) in terms of stage at presentation, management and improvement in quality of life after treatment.
Methodology:A longitudinal study will be conducted at the oncology centres of Rabat and Casablanca with specialized breast cancer management unit. All the breast cancer patients registered with the oncology centers during the first two years of the study will be approached and will be recruited after obtaining written informed consent. We expect to include in the study about 1500 breast cancer patients (1000 in Rabat oncology center and 500 in Casablanca oncology center) each year. A form will be used to extract information from the medical charts of the breast cancer patients from the oncology centres. Data collection will be made by trained staff through visits of the medical records department (MRD). The records of all the recruited patients will be updated every three months to collect information on the clinical stage, histopathology report of the tumour, estrogen receptor status, the post-operative pathology report, the tumour board decision and the adjuvant (or neo-adjuvant) treatment received. The response to treatment and the disease status and vital status at last follow up will be collected from the follow up records. For quality of life assessment, we will use the third version of the QLQ-C30 questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). We will assess the mean duration between detection by CBE or onset of symptoms and the confirmation of diagnosis and onset of treatment, the distribution of breast cancer stage (clinical TNM and pathology TNM), lymph node status, IHC status and type of treatment, the rate of breast conserving surgeries, the treatment response rate and the functional dimensions and symptoms scores on QOL study and improvement between pre- and post-treatment scores by groups.
Funding: Institut de Recherche sur le Cancer (IRC)
Study sites: Ghana: Accra, Kumasi
Principal investigator (PI) from IARC: P. Basu
Study investigators:
  • Beatrice Wiafe Addai, Breast Care International (BCI), Kumasi, Ghana
  • Chiara Scoccianti, IARC, Lyon, France
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Start date: 2017
Closure date:2019
Objectives: The study will assess the following parameters among women who have undergone CBE at the screening clinics conducted by BCI in Ghana:
  • Performance characteristics of the CBE screening methodology (test positivity rate, cancer detection rates, false positivity rate, etc.)
  • The stage distribution of the breast cancers diagnosed through the CBE screening programme
  • The estimated proportion of estrogen receptor (ER)–positive breast cancers among the cancers diagnosed through the CBE screening programme
  • Compliance with referral for disease confirmation among CBE-positive women
  • Compliance with treatment of the breast cancers detected through the programme
  • Response to treatment among the breast cancers detected through the programme
  • Overall and disease-free survival of the women treated for breast cancer
Methodology:This retrospective study will be conducted at the centres in Ghana performing community-based breast cancer screening, as well as at the tertiary care hospitals to which CBE-positive women are referred. Women who underwent breast cancer screening by CBE at the breast cancer screening clinics organized by BCI’s offices in Accra and Kumasi, Ghana, from 1 January 2012 to 31 December 2016 will be included in the study. The paper-based records of the women who have undergone CBE are maintained at the screening centres. The records of the CBE-positive women seen at the tertiary care hospitals are available from the computerized databases maintained at the hospitals. The study questionnaire will allow investigators to reconstruct the patients’ trajectory in the health care system during screening, investigation, treatment, and follow-up.
Funding: Intramural funds from IARC
Study sites: Mumbai, India
Principal investigator (PI) from IARC: R. Sankaranarayanan
PIs from collaborating institutions:Anita Gadgil, Bhabha Atomic Research Centre (BARC) Hospital, Homi Bhabha National Institute University, Mumbai, India
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Start date: 2013
Closure date:2019
Objectives: To implement a programme on breast cancer to increase awareness and early detection by clinical breast examination (CBE) among 22 500 women aged 30–69 years (members of a large health maintenance organization) in order to bring about breast cancer case downstaging, to offer different treatment modalities, and to achieve better survival and quality of life
Methodology:
  • Mail brochures on breast cancer (signs, symptoms, information on self-examination and on breast clinics) to the registered women.
  • Organize regular breast clinics to screen women by CBE.
  • Organize prompt referral of CBE-positive women for mammography, ultrasonography, and cytology.
  • Provide care and follow-up of breast cancer cases.
Publications: Search in Medline for Gadgil A., Roy N., Sankaranarayanan R., Muwonge R., Sauvaget C. Effect of comprehensive breast care on breast cancer outcomes: a community hospital based study from Mumbai, India. Asian Pac J Cancer Prev. 2012;13(4):1105-9.Gadgil A., Roy N., Sankaranarayanan R., Muwonge R., Sauvaget C. Effect of comprehensive breast care on breast cancer outcomes: a community hospital based study from Mumbai, India. Asian Pac J Cancer Prev. 2012;13(4):1105-9.
PMID: 22799289
Search in Medline for Gadgil A., Sauvaget C., Roy N., Grosse Frie K., Chakraborty A., Lucas E., Bantwal K., Haldar I., Sankaranarayanan R. Breast cancer awareness among middle class urban women - a community-based study from Mumbai, India. Asian Pac J Cancer Prev. 2015;16(15):6249-54.Gadgil A., Sauvaget C., Roy N., Grosse Frie K., Chakraborty A., Lucas E., Bantwal K., Haldar I., Sankaranarayanan R. Breast cancer awareness among middle class urban women - a community-based study from Mumbai, India. Asian Pac J Cancer Prev. 2015;16(15):6249-54.
PMID: 26434824
Search in Medline for Gadgil A., Sauvaget C., Roy N., Muwonge R., Kantharia S., Chakrabarty A., Bantwal K., Haldar I., Sankaranarayanan R. Cancer early detection program based on awareness and clinical breast examination: Interim results from an urban community in Mumbai, India. Breast. 2017;31:85-9.Gadgil A., Sauvaget C., Roy N., Muwonge R., Kantharia S., Chakrabarty A., Bantwal K., Haldar I., Sankaranarayanan R. Cancer early detection program based on awareness and clinical breast examination: Interim results from an urban community in Mumbai, India. Breast. 2017;31:85-9.
PMID: 27829200
Search in Medline for Gadgil A., Sauvaget C., Roy N., Muwonge R., Lucas E., Sankaranarayanan R. Setting up a Breast Cancer Awareness Project in Mumbai: Methodology, Experiences and Challenges. J Cancer Educ. 2019 Mar 12. doi: 10.1007/s13187-019-01500-x.Gadgil A., Sauvaget C., Roy N., Muwonge R., Lucas E., Sankaranarayanan R. Setting up a Breast Cancer Awareness Project in Mumbai: Methodology, Experiences and Challenges. J Cancer Educ. 2019 Mar 12. doi: 10.1007/s13187-019-01500-x.
PMID: 30863980
Funding: Bhabha Atomic Research Centre (BARC)



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