Early Detection of Breast Cancer and Cervical Cancer in Women in India

• ClinicalTrials.gov Identifier: NCT00632047
• Recruitment Status: Unknown
• First Posted: March 10, 2008
• Last Update Posted: August 26, 2013
• Sponsor: Tata Memorial Hospital
• Collaborator: National Cancer Institute (NCI)
• Information provided by: National Cancer Institute (NCI)

Tracking Information

• First Submitted Date: March 7, 2008
• First Posted Date: March 10, 2008
• Last Update Posted Date: August 26, 2013
• Study Start Date: May 1998
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 7, 2008): Effectiveness of well planned health education programs and low-cost screening methods (e.g., clinical breast exam and visual inspection of the cervix) in reducing the incidence of and mortality due to breast and cervical cancer
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Detection of Breast Cancer and Cervical Cancer in Women in India
• Official Title: Early Detection of Common Cancers in Women in India

Brief Summary

RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer.

PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

Detailed Description

OBJECTIVES:

• To investigate the effectiveness of well planned health education programs (HEP) and low-cost screening methods (e.g., clinical breast examination [CBE] and visual inspection of the cervix painted with 4% acetic acid [VIA]) in down-staging and reducing the incidence of and mortality due to breast and cervical cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

• Arm I (intervention): Participants undergo intervention comprising health education programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also undergo active surveillance over 8 years.
• Arm II (control): Participants receive one HEP. Participants also undergo active surveillance over 8 years.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Primary Purpose: Screening

Condition

• Breast Cancer
• Cervical Cancer

Intervention

• Other: active surveillance
• Other: educational intervention
• Procedure: examination
• Procedure: long-term screening

• Study Arms: Not Provided

Publications *

• Dinshaw K, Mishra G, Shastri S, Badwe R, Kerkar R, Ramani S, Thakur M, Uplap P, Kakade A, Gupta S, Ganesh B. Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in Mumbai, India. 1. Compliance to screening. Oncology. 2007;73(3-4):145-53. doi: 10.1159/000126497. Epub 2008 Apr 11.
• Dinshaw K, Mishra G, Shastri S, Badwe R, Kerkar R, Ramani S, Thakur M, Uplap P, Kakade A, Gupta S, Ganesh B. Determinants of compliance in a cluster randomised controlled trial on screening of breast and cervix cancer in mumbai, India. 2. Compliance to referral and treatment. Oncology. 2007;73(3-4):154-61. doi: 10.1159/000126498. Epub 2008 Apr 11.
• Mittra I, Mishra GA, Dikshit RP, Gupta S, Kulkarni VY, Shaikh HKA, Shastri SS, Hawaldar R, Gupta S, Pramesh CS, Badwe RA. Effect of screening by clinical breast examination on breast cancer incidence and mortality after 20 years: prospective, cluster randomised controlled trial in Mumbai. BMJ. 2021 Feb 24;372:n256. doi: 10.1136/bmj.n256. Erratum In: BMJ. 2021 Mar 19;372:n738.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 7, 2008): 151538
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 35 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00632047
• Other Study ID Numbers: CDR0000586791; TATA-1900215717A1
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Tata Memorial Hospital
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Surendra S. Shastri, MD; Tata Memorial Hospital

• PRS Account: National Cancer Institute (NCI)
• Verification Date: July 2009