NCT01178736

Early Detection of Cancers in Low Resource Countries

Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 36,000 (estimated)
• Sponsor: Woman's Cancer Foundation · Academic / Other
• Sex: Female
• Age: 30 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Neoplasms
• Uterine Cervical Neoplasms
• Ovarian Neoplasms
• Endometrial Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Breast Cancer Screening and Diagnosis	Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
PROCEDURE	Cervical Cancer Screening and Diagnosis	Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
PROCEDURE	Ovarian Cancer Screening and Diagnosis	Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
PROCEDURE	Endometrial Cancer Screening and Diagnosis	Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-08-10
• Last updated: 2010-08-10

Locations

3 sites across 3 countries: Brazil, Cambodia, India