ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study includes participants with pancreatic cancer who are undergoing genetic testing at Invitae related to their diagnosis of pancreatic cancer.
Our goal in this study is two-fold. First, we would like to research whether any inherited changes in genes may be associated with pancreatic cancer. Second, we would like to learn more about patient experiences with genetic testing, such as patient understanding of the testing, health-related actions taken (or planned to take) as a result of testing, communication and action of family members based on test results, and psychological impact of testing.
This research study involves allowing collection of tumor tissue (from a prior biopsy and/or surgery), a blood sample, and sending surveys to participants for their opinion on the impact of the genetic testing as well as clinicians for relevant baseline and medical history information.
详细描述
Patients will be contacted for patient outcomes survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, and 60. Patients will also be contacted for survival collection every 6 months during years 3-5 post germline testing.
Clinicians will be contacted for relevant medical history, treatment, and survival data at the same time points.
At baseline, 3 samples types will be collected: 1. EDTA tube for germline genetic testing. 2. Streck tubes for whole genome sequencing and other analyses. 3. Tumor block from surgical resection. If block is unavailable 10 unstained slides are an acceptable substitute.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has consented to germline genetic testing
- •Patient has a histologically confirmed diagnosis of pancreatic cancer
- •Patient has undergone or is planned to undergo surgical resection with curative intent
- •Patient is willing to allow collection of a tissue sample from surgical resection
- •Patient is willing to provide research blood samples (every 6 months for 2 years)
- •Patient must be at least 18 years of age
排除标准
- •Patient has evidence of metastatic or recurrent pancreatic cancer at time of consent
- •Patient is unable to consent.
结局指标
主要结局
Overall survival
时间窗: Will be assessed every 6 months for years 2 - 10 post germline testing
Germline pathogenic variants identified on Invitae's 84 gene Multi Cancer panel
时间窗: Will be assessed at baseline only.
次要结局
未报告次要终点