Clinical trial · Interventional
Trivandrum Breast Cancer Screening Trial
Evaluating of Clinical Early Detection of Breast Cancer in Trivandrum District, India
NCT05301296CI-TRIAL-00057374TBCScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical examination of the breast for early detection of Cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- Standard of Care.
- type
- ACTIVE_COMPARATOR
- label
- Intervention Arm
- description
- Clinical examination of the breast for early detection of Cancer.
- interventionNames
- Diagnostic Test: Clinical examination of the breast for early detection of Cancer
Primary outcomes (2)
- measure
- Breast Cancer Death Rate
- timeFrame
- 14 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P, Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results from a cluster randomized controlled trial in India. J Natl Cancer Inst. 2011 Oct 5;103(19):1476-80. doi: 10.1093/jnci/djr304. Epub 2011 Aug 23. PMID 21862730