An interventional study of Clinical examination of the breast for early detection of Cancer in Breast Cancer, sponsored by International Agency for Research on Cancer. Completed. Open to participants aged 30 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by International Agency for Research on Cancer · Not applicable, Interventional, and Screening
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.
The study population consisted of 274 administrative regions (clusters) in Trivandrum district, Kerala, southern Indian. 133 clusters were randomly assigned to the intervention arm (3 rounds of clinical breast examination conducted 3 years apart) and were compared to the remaining 141 clusters assigned to a control arm that received standard of care. The eligibility criteria were all healthy subjects aged 30 to 69, without a personal history of breast cancer. Informed consent was signed by each participant. The intervention arm consisted of 55,843 participants and the control group consisted of 59,447 participants.
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This study's enrollment of 115,290 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Standard of Care.
Clinical examination of the breast for early detection of Cancer.
Diagnostic Test: Clinical examination of the breast for early detection of Cancer
Participants were invited for 3 rounds of clinical breast examination, conducted 3-years apart. Screening was conducted by health workers trained to perform clinical breast examination for early detection of cancer. Women with abnormal referable lesions underwent CBE by a trained clinician and those women with a confirmed breast lump or any other breast abnormality warranting further investigations were evaluated by triple-testing involving expert physical examination, diagnostic mammography with or without ultrasonography and fine needle aspiration cytology (FNAC) or core biopsy or excision biopsy. Those with confirmed breast cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
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.
Time frame: 14 years
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.
Time frame: 14 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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International Agency for Research on Cancer