Breast Cancer Clinical Trial
— TBCSOfficial title:
Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
Verified date | March 2022 |
Source | International Agency for Research on Cancer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cluster-randomized controlled trial in Trivandrum district, Kerala, India to evaluate the effect of triennial screening for breast cancer using clinical breast examination on breast cancer mortality.
Status | Completed |
Enrollment | 115290 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 69 Years |
Eligibility | Inclusion Criteria: - Residing in 274 study clusters in Trivandrum City, Kerala Exclusion Criteria: - Diagnosis with breast cancer prior to study - Bedridden subjects - Subjects suffering from open tuberculosis or other debilitating diseases |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
International Agency for Research on Cancer | Regional Cancer Centre, Trivandrum, India |
Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast Cancer Death Rate | Information on all deaths were collected from the municipal and district death registers, hospital medical records, death records of churches and mosques, hospital visits by the population cancer registry staff and by project health workers. Cancer cases were coded by the ICD-O 3rd edition codes and cause of death was coded using ICD-10 by the registry and project staff blinded to study group allocation. Deaths were attributed to breast cancer if the patient had histologically or clinically confirmed breast cancer, lymph nodes or distant metastasis at the time of death or had died due to complications of breast cancer treatment. | 14 years | |
Primary | Breast Cancer Incidence | Information on incident breast cancer cases were obtained from the Trivandrum population-based cancer registry, hospital cancer registry of the RCC and medical records departments of other hospitals treating breast cancer patients. Collection of information was blinded to study group assignment of cases. The staging of breast cancers was done according to the UICC TNM staging system. | 14 years |
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