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Early Detection of Cancers in Low Resource Countries

NCT01178736UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Woman's Cancer Foundation

Enrollment

36000

Start Date

2011-03-01

Completion Date

2014-03-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Breast Cancer Screening and DiagnosisCervical Cancer Screening and DiagnosisOvarian Cancer Screening and DiagnosisEndometrial Cancer Screening and Diagnosis

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsOvarian NeoplasmsEndometrial Neoplasms

Eligibility

Age Range

30 Years – 64 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology

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.

Time frame: Three (3) year interval

Secondary Outcomes

Effectiveness of CBE and Ultrasonography for Breast Cancer Detection

This study will examine the effectiveness of Clinical Breast Examination combined with Ultrasonography for breast cancer screening and detection in low resource settings where X-ray mammography proves not feasible in terms of cost, technology, and staff.

Time frame: Three (3) year interval

Locations

Hospital de Cancer de Barretos, São Paulo, Brazil

Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia, Phnom Penh, Cambodia

Manipal Healthcare Group, Goa, India