Early Detection of Cancers in Low Resource Countries
Recruitment status was Not yet recruiting
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.
Uterine Cervical 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
|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|
- The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology [ Time Frame: Three (3) year interval ] [ Designated as safety issue: No ]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.
- Effectiveness of CBE and Ultrasonography for Breast Cancer Detection [ Time Frame: Three (3) year interval ] [ Designated as safety issue: No ]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.
|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)|
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: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 DNAProcedure: Ovarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
Other Name: UltrasoundProcedure: Endometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Other Name: Ultrasound
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178736
|Hospital de Cancer de Barretos||Not yet recruiting|
|Sao Paolo, Brazil|
|Contact: Edmundo Mauad, MD, PhD (17) 3321-6600 email@example.com|
|Principal Investigator: Edmundo Mauad, MD, PhD|
|Sihanouk Hospital Center of Hope, Hope Worldwide Cambodia||Not yet recruiting|
|Phnom Penh, Cambodia|
|Contact: Cornelia Haener, MD (855-23) 882-484 firstname.lastname@example.org|
|Contact: Shelly Malhotra email@example.com|
|Principal Investigator: Cornelia Haener, MD|
|Manipal Healthcare Group||Not yet recruiting|
|Contact: R.G. Pinto, MD firstname.lastname@example.org|
|Principal Investigator: Sharmila Sardesai, MD|
|Principal Investigator: R. G. Pinto, MD|
|Principal Investigator: Eugene D'Silva, MD|
|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|