Trivandrum Breast Cancer Screening Trial

NCT05301296 | Completed

• 1 other identifier: IEC 05-05
• Study Type: interventional
• Target: 115,290
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Arm

NO INTERVENTION

Standard of Care.

Intervention Arm

ACTIVE COMPARATOR

Clinical examination of the breast for early detection of Cancer.

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

Interventions

Clinical examination of the breast for early detection of Cancer DIAGNOSTIC_TEST

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.

Intervention Arm

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Residing in 274 study clusters in Trivandrum City, Kerala

You may not qualify if:

• Diagnosis with breast cancer prior to study
• Bedridden subjects
• Subjects suffering from open tuberculosis or other debilitating diseases

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Regional Cancer Centre, Trivandrum, India: collaborator

Related Publications (1)

• Sankaranarayanan 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Early Diagnosis; Diagnosis

Study Officials

• Kunnambath Ramadas, MD. DNB. FAMS, PhD

  Regional Cancer Centre, Trivandrum, India

  PRINCIPAL INVESTIGATOR

• Rengaswamy Sankaranarayanan, MD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Cancer registry staff members blinded to study group assignments collected data on the date of diagnosis, stage, treatment and follow-up details of breast cancer patients by visiting hospitals and laboratories where breast cancer cases are diagnosed and treated. The cause of death was assessed by two independent experts blinded to group allocation after evaluation of data from hospital records, death certificates, house visits and interviews of relatives and friends.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: January 1, 2006
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share