NCT00632047

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

Early Detection of Common Cancers in Women in India

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151,538 (estimated)
• Sponsor: Tata Memorial Hospital · Other Government
• Sex: Female
• Age: 35 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Cervical Cancer

Interventions

Type	Name	Description
OTHER	active surveillance
OTHER	educational intervention
PROCEDURE	examination
PROCEDURE	long-term screening

Timeline

• Start date: 1998-05-01
• Primary completion: 2015-12-01
• First posted: 2008-03-10
• Last updated: 2013-08-26

Locations

1 site across 1 country: India