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RecruitingObservational

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

NCT ID: NCT06589310Sponsor: Exact Sciences CorporationLast updated: 2026-05-22

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

Sex: AllAge: 50 Years to 80 YearsHealthy volunteers: Yes
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations (2)

Endeavor Health

Evanston, Illinois, 60201

Recruiting
Peter Hulick, M.D. · Contact
Henry (Mark) Dunnenberger, PharmD · Contact
Peter Hulick, M.D. · Principal Investigator

Baylor Scott & White Health

Dallas, Texas, 75246

Recruiting
Keisha Riser, MBA · Contact
Ronan Kelly, M.D. · Principal Investigator
Falcon Real World Evidence Registry | Cancerify