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Early Detection of Cancers in Low Resource Countries

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Woman's Cancer Foundation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178736
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Woman's Cancer Foundation
  Purpose
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.

Condition Intervention Phase
Breast Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Endometrial Neoplasms Procedure: Breast Cancer Screening and Diagnosis Procedure: Cervical Cancer Screening and Diagnosis Procedure: Ovarian Cancer Screening and Diagnosis Procedure: Endometrial Cancer Screening and Diagnosis Early Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries

Resource links provided by NLM:


Further study details as provided by Woman's Cancer Foundation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 36000
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • FNAB
  • CBE
  • Ultrasound
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 Name: HPV DNA
Procedure: Ovarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Other Name: Ultrasound
Procedure: Endometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Other Name: Ultrasound

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178736


Locations
Brazil
Hospital de Cancer de Barretos Not yet recruiting
Sao Paolo, Brazil
Contact: Edmundo Mauad, MD, PhD    (17) 3321-6600    ecmauad@hcancerbarretos.com.br   
Principal Investigator: Edmundo Mauad, MD, PhD         
Cambodia
Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia Not yet recruiting
Phnom Penh, Cambodia
Contact: Cornelia Haener, MD    (855-23) 882-484    corneliahaener@sihosp.org   
Contact: Shelly Malhotra       shellymalhotra@sihosp.org   
Principal Investigator: Cornelia Haener, MD         
India
Manipal Healthcare Group Not yet recruiting
Goa, India
Contact: R.G. Pinto, MD       rgwpinto@gmail.com   
Principal Investigator: Sharmila Sardesai, MD         
Principal Investigator: R. G. Pinto, MD         
Principal Investigator: Eugene D'Silva, MD         
Sponsors and Collaborators
Woman's Cancer Foundation
Investigators
Principal Investigator: Weiwei Yang, MD M.D. Anderson Cancer Center, University of Texas
Principal Investigator: Diljeet K Singh, MD Feinberg School of Medicine, Northwestern University
Principal Investigator: Adhemar Longatto Filho, MD University of Sao Paolo
  More Information

Publications:

Responsible Party: Mahesh Shetty, MD/President, Woman's Cancer Foundation
ClinicalTrials.gov Identifier: NCT01178736     History of Changes
Other Study ID Numbers: WCF-2011-BRA-IND-CAM
First Submitted: August 6, 2010
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
Last Verified: August 2010

Keywords provided by Woman's Cancer Foundation:
neoplasms

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases