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Trivandrum Breast Cancer Screening Trial

NCT05301296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115290

Last updated 2022-03-29

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Clinical examination of the breast for early detection of Cancer

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.

Sponsors & Collaborators

  • Regional Cancer Centre, Trivandrum, India

    collaborator OTHER

  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Kunnambath Ramadas, MD. DNB. FAMS, PhD · Regional Cancer Centre, Trivandrum, India

  • Rengaswamy Sankaranarayanan, MD · International Agency for Research on Cancer

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-01
Primary Completion
2014-12-31
Completion
2019-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301296 on ClinicalTrials.gov