A Multi-center Prospective Observational Study of Community Urology Practices Applying Germline Genetic Testing for Prostate Cancer Patients (PROCLAIM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 19
- 主要终点
- Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
研究概览
简要总结
This registry is for men who have prostate cancer and have had multigene panel hereditary testing. The registry will gather data on genetic testing results and how that information may change physician treatment or follow up recommendations. It will also gather data on the patient's experience with genetic testing, through a post-test survey to be completed 60-90days after results have been received and discussed with their provider.
详细描述
This registry will enroll men with prostate cancer who have done multi-gene testing for their cancer. Patients will be enrolled into two cohorts, one for individuals who meet current NCCN testing guidelines, and one for individuals who do not meet current NCCN guidelines.
The main goal of this Registry is to assess whether nationally developed guidelines used to select patients for hereditary testing are adequate to identify all patients with prostate cancer who may benefit from testing. Patients will completed a post-test survey regarding their testing experience and clinicians will be asked to provide additional medical records review information via the Clinician Report Form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men ages 18-90 who have been prescribed genetic testing as part of their clinical care
- •Have prostate cancer at any stage, either actively under treatment or being followed who either:
- •meet NCCN criteria for testing or
- •do not meet NCCN criteria for testing
- •Patients who are naive to clinical genetic testing for BRCA1/BRCA2 (single gene panel testing)
排除标准
- •Mental or cognitive impairment that interferes with ability to provide informed consent
结局指标
主要结局
Diagnostic yield of pathogenic and likely pathogenic genes in the patient population
时间窗: to be assessed at baseline only
Identify the diagnostic yield of pathogenic/likely pathogenic variants in known cancer syndrome genes in patients with prostate cancer, using the Invitae 84 gene multi-cancer panel. These rates will be compared between the two cohorts.
次要结局
- Evaluate the impact of genetic test results on clinical management decisions(60-90 days post test results received.)
- Evaluate the sensitivity of current NCCN criteria for germline genetic testing for identifying prostate cancer patients that have pathogenic/likely pathogenic variants(at baseline only)