Breast Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
Conditions
Keywords
neoplasms
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.
Interventions
PROCEDUREBreast Cancer Screening and Diagnosis
Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
PROCEDURECervical Cancer Screening and Diagnosis
Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
PROCEDUREOvarian Cancer Screening and Diagnosis
Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
PROCEDUREEndometrial Cancer Screening and Diagnosis
Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
Sponsors
Woman's Cancer Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil, Cambodia, India
Outcome results
None listed