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
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|
- 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 (Clinical Trial)|
|Estimated Enrollment :||151538 participants|
|Official Title:||Early Detection of Common Cancers in Women in India|
|Study Start Date :||May 1998|
|Estimated Primary Completion Date :||December 2015|
- 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
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
|Tata Memorial Hospital||Recruiting|
|Mumbai, India, 400012|
|Contact: Surendra S. Shastri, MD 91-22-2415-4379|
|Principal Investigator:||Surendra S. Shastri, MD||Tata Memorial Hospital|