Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25,000
- 试验地点
- 4
- 主要终点
- Vital status
研究概览
简要总结
This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.
详细描述
This study was designed to simulate a real-world application of Exact Science's Multicancer Early Detection (MCED) test. Participants will be offered the Exact Science's MCED test annually for 3 years. If at any point during those 3 years a participant is diagnosed with cancer, they will become ineligible for further testing. Data will be collected for 5 years following the baseline test.
There will be two data collection approaches as part of this study. The first will be collection of self-report data related to the testing experience. The second will be periodic and largely automated extraction of pre-specified data elements from existing electronic data sources. A comparison data set will be constructed from records of individuals who did not receive the MCED test.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant age at time of consent is between 50 and 80 years
- •Agree to receive the Exact Sciences MCED test and follow-up imaging
- •Willing and able to provide informed consent
- •Access to a suitable technology and willing to complete surveys electronically
排除标准
- •Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery
研究组 & 干预措施
Multicancer Early Detection (MCED) cohort
干预措施: Exact Sciences Multicancer Early Detection (MCED) Test (Device)
结局指标
主要结局
Vital status
时间窗: Up to 5 years
Particpant is alive or deceased
Cancer status
时间窗: Up to 5 years
Presence or absence of cancer
次要结局
未报告次要终点