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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)

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 151538 participants
Allocation: Randomized
Primary Purpose: Screening
Official Title: Early Detection of Common Cancers in Women in India
Study Start Date : May 1998
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632047


Locations
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India
Tata Memorial Hospital Recruiting
Mumbai, India, 400012
Contact: Surendra S. Shastri, MD    91-22-2415-4379      
Sponsors and Collaborators
Tata Memorial Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Surendra S. Shastri, MD Tata Memorial Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00632047    
Other Study ID Numbers: CDR0000586791
TATA-1900215717A1
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
breast cancer
cervical cancer
Additional relevant MeSH terms:
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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