Trivandrum Breast Cancer Screening Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Clinical examination of the breast for early detection of Cancer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control group received standard of care while the intervention group received 3 rounds of screening with clinical breast examination, each 3 years apart. After the 3 rounds of screening, the participants were followed up for an additional 4 years to accrue information on breast cancer incidence and mortality, and the vital status.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Standard of Care. | |
| Active Comparator: Intervention Arm<br>Clinical examination of the breast for early detection of Cancer. | Diagnostic Test: Clinical examination of the breast for early detection of Cancer<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |