Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Woman's Cancer Foundation
- Enrollment
- 36000
- Locations
- 3
- Primary Endpoint
- The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to implement a community-based combined program for early detection of breast, cervical, ovarian and endometrial cancer in low-resource countries delivered through a free standing or a mobile Well Woman Clinic. The goals of this program are to downstage cancers and improve mortality rates using low-cost early detection methods. These programs will be implemented in regions where early cancer detection strategies are not in place and cancers present at advanced stages with resultant high mortality. Currently, there are three target project sites: Cambodia (June 2011), India (June 2011), and Brazil (March 2011). Memorandums of Understanding have been secured with local health organizations in each region to establish clinic operations. Each clinic would serve an approximate target population of 100,000 amongst whom about 12,000 eligible women (4-5,000 annually) will be invited to be screened for breast and cervical cancer over a three-year time span.
Detailed Description
We will study the use of sonographic screening in addition to Clinical Breast Examination in low resource settings where screening programs are not currently in place and establishing a population based mammographic screening would be expensive, resource intensive, and difficult if not impossible to implement. The effectiveness of the screening and diagnostic methodology used for early detection of breast, cervical, ovarian and endometrial cancers in low resource settings will be studied. The program would involve screening of asymptomatic women for Breast and Cervical cancer and diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer. Women in the age group of 30-59 yrs will be screened once every three years utilizing the following methods: Breast - clinical breast examination \[CBE\] and Sonography, followed by Fine needle aspiration biopsy (FNAB) of screen positive cases; Cervical - Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases (Single visit, screen and treat approach); Ovarian - Transvaginal sonogram and clinical evaluation; Endometrial - Transvaginal sonographic assessment of the endometrial stripe.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Breast Cancer: women age 35-64
- •Cervical Cancer: women age 30-59
- •Ovarian Cancer: symptomatic post menopausal women age 50-64
- •Endometrial Cancer: symptomatic post menopausal women age 50-64
Exclusion Criteria
- •women under the age of 30
Outcomes
Primary Outcomes
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
Time Frame: Three (3) year interval
This study will examine the effectiveness of an innovative, low-cost screening and diagnostic methodology used for combined early detection of breast and gynecological cancers in low resource regions where early cancer detection strategies are not in place and cancers currently are diagnosed at advanced stages with resultant high mortality.
Secondary Outcomes
- Effectiveness of CBE and Ultrasonography for Breast Cancer Detection(Three (3) year interval)