Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
Summary
This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.
Detailed description
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.
Arms & interventions
- DeviceExact Sciences Multicancer Early Detection (MCED) Test
Exact Sciences MCED test, is a qualitative in vitro diagnostic (IVD) for the detection of alterations in circulating tumor DNA and tumor-associated protein levels, which are commonly associated with cancer. It is performed on plasma derived from peripheral blood specimens.
Outcome measures
Primary
Vital status
Particpant is alive or deceased
Time frame: Up to 5 years
Cancer status
Presence or absence of cancer
Time frame: Up to 5 years
Eligibility criteria
Study locations (2)
Endeavor Health
Evanston, Illinois, 60201
Baylor Scott & White Health
Dallas, Texas, 75246