Early Detection of Cancers in Low Resource Countries

Woman's Cancer Foundation

Status: Unknown

Conditions: Ovarian Neoplasms; Uterine Cervical Neoplasms; Breast Neoplasms; Endometrial Neoplasms

Treatments: Procedure: Endometrial Cancer Screening and Diagnosis; Procedure: Ovarian Cancer Screening and Diagnosis; Procedure: Cervical Cancer Screening and Diagnosis; Procedure: Breast Cancer Screening and Diagnosis

Study type: Observational

Funder types: Other

Identifiers

NCT01178736

WCF-2011-BRA-IND-CAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36,000 estimated patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36,000 participants in 1 patient group

Cancer Screening and Diagnosis

Description:

Screening of asymptomatic women for Breast and Cervical cancer in the age group of 35-64 years. Diagnostic assessment of symptomatic women for Ovarian and Endometrial cancer in the age group of 50-64 years.

Treatment:

Procedure: Breast Cancer Screening and Diagnosis

Procedure: Cervical Cancer Screening and Diagnosis

Procedure: Ovarian Cancer Screening and Diagnosis

Procedure: Endometrial Cancer Screening and Diagnosis