NCT05301296

Trivandrum Breast Cancer Screening Trial

Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115,290 (actual)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: All
• Age: 30 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-01-01
• Primary completion: 2014-12-31
• Completion: 2019-12-31
• First posted: 2022-03-29
• Last updated: 2022-03-29