Trivandrum Breast Cancer Screening Trial

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

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.

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