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Early Detection of Cancers in Low Resource Countries
Conditions
Breast Neoplasms - Uterine Cervical Neoplasms - Ovarian Neoplasms - Endometrial Neoplasms
Conditions: official terms
Breast Neoplasms - Endometrial Neoplasms - Neoplasms - Ovarian Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
neoplasms
Study Type
Observational
Study Phase
Phase 0
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Breast Cancer Screening and Diagnosis
Type: Procedure
Name: Cervical Cancer Screening and Diagnosis
Type: Procedure
Name: Ovarian Cancer Screening and Diagnosis
Type: Procedure
Name: Endometrial Cancer Screening and Diagnosis
Type: Procedure
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 64 Years
Minimum Age: 30 Years
Gender: Female
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
- 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
Locations
Hospital de Cancer de Barretos
Sao Paolo, Brazil
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia
Status: Not yet recruiting
Contact: Edmundo Mauad, MD, PhD - (17) 3321-6600 - ecmauad@hcancerbarretos.com.br
Phnom Penh, Cambodia
Manipal Healthcare Group
Status: Not yet recruiting
Contact: Cornelia Haener, MD - (855-23) 882-484 - corneliahaener@sihosp.org
Goa, India
Status: Not yet recruiting
Contact: R.G. Pinto, MD - rgwpinto@gmail.com
Start Date
March 2011
Completion Date
March 2014
Sponsors
Woman's Cancer Foundation
Source
Woman's Cancer Foundation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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