NCT06589310

Falcon Real World Evidence Registry

Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25,000 (estimated)
• Sponsor: Exact Sciences Corporation · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DEVICE	Exact 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2030-08-01
• Completion: 2031-01-01
• First posted: 2024-09-19
• Last updated: 2025-05-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study