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Spots Global Cancer Trial Database for Early Detection of Breast Cancer and Cervical Cancer in Women in India

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Trial Identification

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

Study ID: NCT00632047

Study Description

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.

Eligibility

Minimum Age: 35 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tata Memorial Hospital, Mumbai, , India

Contact Details

Name: Surendra S. Shastri, MD

Affiliation: Tata Memorial Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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