NCT01851109已完成不适用
Prevention of Ovarian Cancer in Women Participating in Mammography
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 2
- 主要终点
- Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
研究概览
简要总结
The primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in Seattle, WA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Prior mammogram at Swedish Medical Center
- •Willing and able to provide informed consent, primary physician information, and complete study questionnaires
- •Must meet at least ONE of the following criteria:
- •personal history of breast cancer diagnosed before age 50
- •personal history of bilateral breast cancer at any age
- •1 or more first degree relatives with breast cancer diagnosed before age 50
- •3 or more first or second degree relatives with breast cancer at any age
- •2 second degree relatives with breast cancer diagnosed before age 50
- •A male relative with breast cancer at any age
- •Ashkenazi Jewish with any family history of breast or ovarian cancer
- •1 first or second degree relative with ovarian cancer AND 1 first or second degree relative with breast cancer at any age
- •2 first degree relatives with ovarian cancer or 2 second degree relatives with ovarian cancer or 1 first and 1 second degree relative with ovarian cancer.
- •A first degree relative with both breast and ovarian cancer (2 primaries in the same person)
- •Personal history of positive genetic test result for any of the following genes: BRCA1, BRCA2, HNPCC, or P53
- •Family history of a positive genetic test result for any of the following genes: BRCA1, BRCA2 or HNPCC
排除标准
- •Previous diagnosis of ovarian cancer
- •Prior bilateral-salpingo oophorectomy
- •Had a negative genetic test result for a known family genetic mutation
结局指标
主要结局
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
时间窗: 24 months post-enrollment
次要结局
- Cancer related distress(change from baseline at 12 and 24 months post-enrollment)
- Health-related quality of life(change from baseline at 12 and 24 months post-enrollment)
研究者
研究点 (2)
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