Early Detection of Cancers in Low Resource Countries

• Conditions: Breast Neoplasms; Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms
• Interventions: Procedure: Breast Cancer Screening and Diagnosis; Procedure: Cervical Cancer Screening and Diagnosis; Procedure: Ovarian Cancer Screening and Diagnosis; Procedure: Endometrial Cancer Screening and Diagnosis

• Registration Number: NCT01178736
• Lead Sponsor: Woman's Cancer Foundation

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.

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-08
• Last Update Submitted: 2010-08-08
• Study First Posted: 2010-08-10
• Last Update Posted: 2010-08-10
• Study Start: 2011-03
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer Screening and Diagnosis	Breast Cancer Screening and Diagnosis	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.
Cancer Screening and Diagnosis	Cervical Cancer Screening and Diagnosis	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.
Cancer Screening and Diagnosis	Ovarian Cancer Screening and Diagnosis	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.
Cancer Screening and Diagnosis	Endometrial Cancer Screening and Diagnosis	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.

Primary Outcome Measures

Name	Time	Method
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology	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 Outcome Measures

Name	Time	Method
Effectiveness of CBE and Ultrasonography for Breast Cancer Detection	Three (3) year interval	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.

Trial Locations

Locations (3)

Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia; 🇰🇭 Phnom Penh, Cambodia

Manipal Healthcare Group; 🇮🇳 Goa, India

Hospital de Cancer de Barretos; 🇧🇷 Sao Paolo, Brazil