Falcon - multicancer early detection (MCED) real-world evidence (RWE) registry

Falcon is a multi-site prospective registry study of a blood-based multi-biomarker multi-cancer early detection (mb-MCED) test in individuals who seek cancer screening to characterize clinical care and outcomes and assess the psychological impact of MCED testing.Falcon is enrolling ≥ 25,000 U.S. participants who receive the MCED test annually for 3 years (MCED cohort) and a matched comparison cohort of ≥50,000 participants receiving standard-of-care clinical management only (SOC cohort). Cohorts will include individuals 50-80 years of age presenting for primary care services who have no current suspicion or history of cancer within 3 years. SOC cancer screening will continue as recommended.The MCED cohort will include MCED testing and follow-up IV-contrast computed tomography and, if necessary, positron emission tomography-CT imaging following a positive test. Self-reported measures of anxiety, worry, and distress will be collected from MCED cohort participants for ≥5 years and following an index date for the SOC cohort. Time from positive MCED to diagnostic imaging and biopsy to first oncologic appointment will be recorded. Smart phone applications will be used to remotely interact with patients to improve health care coordination. Data will be collected for ≥5 years.Clinical trial registration: www.clinicaltrials.gov identifier: NCT06589310 (V3, 5-2025).