Trivandrum Breast Cancer Screening Trial
- Conditions
- Breast Cancer
- Interventions
- Diagnostic Test: Clinical examination of the breast for early detection of Cancer
- Registration Number
- NCT05301296
- Lead Sponsor
- International Agency for Research on Cancer
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115290
- Residing in 274 study clusters in Trivandrum City, Kerala
- Diagnosis with breast cancer prior to study
- Bedridden subjects
- Subjects suffering from open tuberculosis or other debilitating diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Clinical examination of the breast for early detection of Cancer Clinical examination of the breast for early detection of Cancer.
- Primary Outcome Measures
Name Time Method Breast Cancer Incidence 14 years 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.
Breast Cancer Death Rate 14 years 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.
- Secondary Outcome Measures
Name Time Method