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

This study is currently recruiting participants.
Verified July 2009 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00632047
First received: March 7, 2008
Last updated: August 23, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Cervical Cancer
Other: active surveillance
Other: educational intervention
Procedure: examination
Procedure: long-term screening
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Screening
Official Title: Early Detection of Common Cancers in Women in India

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: Yes ]

Estimated Enrollment: 151538
Study Start Date: May 1998
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632047

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, India, 400012
Contact: Surendra S. Shastri, MD    91-22-2415-4379      
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: Surendra S. Shastri, MD Tata Memorial Hospital
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00632047     History of Changes
Other Study ID Numbers: CDR0000586791, TATA-1900215717A1
Study First Received: March 7, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
breast cancer
cervical cancer

Additional relevant MeSH terms:
Breast Neoplasms
Uterine Cervical Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014