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Early Detection of Cancers in Low Resource Countries

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ClinicalTrials.gov Identifier: NCT01178736
Recruitment Status : Unknown
Verified August 2010 by Woman's Cancer Foundation.
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2010
Last Update Posted : August 10, 2010
Sponsor:
Information provided by:
Woman's Cancer Foundation

August 6, 2010
August 10, 2010
August 10, 2010
March 2011
March 2014   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Early Detection of Cancers in Low Resource Countries
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
  • Breast Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Endometrial Neoplasms
  • 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
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.
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
36000
Same as current
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
30 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil,   Cambodia,   India
 
 
NCT01178736
WCF-2011-BRA-IND-CAM
No
Not Provided
Not Provided
Mahesh Shetty, MD/President, Woman's Cancer Foundation
Woman's Cancer Foundation
Not Provided
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
Woman's Cancer Foundation
August 2010