Efficacy of a Combined Program for Early Detection of Breast and Gynecological Cancers in Low Resource Countries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36,000
- 试验地点
- 3
- 主要终点
- The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •women under the age of 30
结局指标
主要结局
The Effectiveness of an Innovative, Low-Cost Screening and Diagnostic Methodology
时间窗: 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.
次要结局
- Effectiveness of CBE and Ultrasonography for Breast Cancer Detection(Three (3) year interval)