Early Detection of Cancers in Low Resource Countries

August 8, 2010 updated by: Woman's Cancer Foundation

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

36000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paolo, Brazil
        • Hospital de Cancer de Barretos
  • Cambodia
      • Phnom Penh, Cambodia
        • Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia
  • India
      • Goa, India
        • Manipal Healthcare Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Brazil has two rural hospitals serving a population of roughly 46,000 people (Nova Andradina) inside Mato Grosso do Sul, which has a population of over 2 million. Cambodia has a population of over 1 million inside the Phnom Penh metropolitan area. India has a population of more than 1.3 million inside the state of Goa. According to the NFHS-2, nearly 30 percent of rural Goan women live 10 or more kilometers away from a primary health center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Breast Cancer Screening and Diagnosis
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
Other Names:
  • Ultrasound
  • CBE
  • FNAB
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.
Other Names:
  • HPV DNA
Procedure: Ovarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Other Names:
  • Ultrasound
Procedure: Endometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Other Names:
  • Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
Time Frame: 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.
Three (3) year interval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of CBE and Ultrasonography for Breast Cancer Detection
Time Frame: 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.
Three (3) year interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Woman's Cancer Foundation

Investigators

  • Principal Investigator: Weiwei Yang, MD, M.D. Anderson Cancer Center, University of Texas
  • Principal Investigator: Diljeet K Singh, MD, Northwestern University Feinberg School of Medicine
  • Principal Investigator: Adhemar Longatto Filho, MD, University of Sao Paolo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

August 6, 2010

First Submitted That Met QC Criteria

August 8, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 8, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCF-2011-BRA-IND-CAM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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