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Trial record 1 of 1 for:    NCT00632047
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Early Detection of Breast Cancer and Cervical Cancer in Women in India

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ClinicalTrials.gov Identifier: NCT00632047
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 10, 2008
Last Update Posted : August 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 7, 2008
First Posted Date  ICMJE March 10, 2008
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE May 1998
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Detection of Breast Cancer and Cervical Cancer in Women in India
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Screening
Condition  ICMJE
  • Breast Cancer
  • Cervical Cancer
Intervention  ICMJE
  • Other: active surveillance
  • Other: educational intervention
  • Procedure: examination
  • Procedure: long-term screening
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2008)
151538
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632047
Other Study ID Numbers  ICMJE CDR0000586791
TATA-1900215717A1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Tata Memorial Hospital
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Surendra S. Shastri, MD Tata Memorial Hospital
PRS Account National Cancer Institute (NCI)
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP