Trivandrum Breast Cancer Screening Trial (TBCS)

International Agency for Research on Cancer

Status: Completed

Conditions: Breast Cancer

Treatments: Diagnostic Test: Clinical examination of the breast for early detection of Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT05301296

IEC 05-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115,290 patients

Sex: All

Ages: 30 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

115,290 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Standard of Care.

Intervention Arm

Active Comparator group

Description:

Clinical examination of the breast for early detection of Cancer.

Treatment:

Diagnostic Test: Clinical examination of the breast for early detection of Cancer