Genetic Evaluation of Men (GEM)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 595
- 试验地点
- 3
- 主要终点
- Genetic and genomic sequencing
研究概览
简要总结
This is a prospective research registry and prospective genetic testing cohort study. The goal is to collect personal medical and cancer history data, family cancer data, exposure history, and biospecimens to support research focused on optimal genetic testing strategies for men with prostate cancer with the ultimate goal of informing national guidelines focused on genetic evaluation for prostate cancer.
详细描述
Objectives:
- Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility.
- Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process.
- Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk.
- Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk.
- Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with a personal history of prostate cancer
- •Unaffected males who are at higher risk for prostate cancer
排除标准
- •Age < 18 years
- •Mental or cognitive impairment that interferes with ability to provide informed consent
- •Social circumstances that may impair the ability to follow through with study or provide informed consent (such as homelessness, drug/alcohol dependence, etc.)
结局指标
主要结局
Genetic and genomic sequencing
时间窗: Three years
Perform targeted and broad-scale genetic and genomic sequencing to detect genetic alterations related to prostate cancer risk
Family cancer history collection
时间窗: Three years
Collect detailed family cancer histories, personal medical history, prostate cancer clinical features, and exposure history from men with prostate cancer and men without prostate cancer to support studies focused on identifying hereditary cancer syndromes and genetic/epidemiologic factors predisposing to prostate cancer susceptibility.
Biospecimen bank
时间窗: Three years
Create and maintain a biospecimen bank with specimens from men with prostate cancer and without prostate cancer to support studies focused on genetic alterations predisposing to prostate cancer risk
Behavioral measure collection
时间窗: Three years
Collect behavioral measures to support research focused on assessing the needs of men undergoing cancer risk evaluation and satisfaction with the process
Participant follow-up
时间窗: Three years
Develop mechanisms to recontact participants with updates on research genetic results to guide genetic testing for inherited prostate cancer risk.
次要结局
未报告次要终点