Universal Genetic Testing for Cancer Risk Reduction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Number of participants who undergo genetic testing
研究概览
简要总结
The purpose of this research study is to see if offering genetic testing for cancer-related genes is feasible and acceptable for patients presenting for gynecology clinic visits, instead of needing to see specialized providers or needing to meet specific criteria. The primary aim to assess the proportion of patients who undergo genetic testing, and the proportion of patients with pathogenic variants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients between ages of 25-39 years at the time of visit
- •Receive gynecologic care at an affiliated NYU Langone Health (NYULH) site listed in this protocol.
排除标准
- •Personal history of ovarian, fallopian tube, primary peritoneal, or uterine cancers
- •Previously undergone germline testing for ovarian cancer risk variants (prior commercial saliva-based kits, such as 23andMe, are acceptable)
- •History of bilateral salpingo-oophorectomy
- •Visit related to pregnancy or immediately postpartum (within 2 weeks)
研究组 & 干预措施
Completed genetic screening test
Participants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team.
干预措施: Natera® Empower™ hereditary cancer panel test (Genetic)
Completed genetic screening test
Participants will complete point-of-care genetic testing by saliva test. Participants with actionable pathogenic variants will be referred to the appropriate specialists to discuss risk-reduction strategies and offered genetic counseling. All Participants will be given the opportunity for genetic counseling, and if interested and desired this will be facilitated by the research team.
干预措施: Specialist Referral (Other)
Denied genetic screening test
Participants in this arm have declined the genetic screening test.
结局指标
主要结局
Number of participants who undergo genetic testing
时间窗: Up to 9 months
Outcome measure will be assessed via review of electronic medical record (EMR).
次要结局
- Number of participants with pathogenic variants(Up to 9 months)