Falcon Real World Evidence Registry

May 20, 2026 updated by: Exact Sciences Corporation

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

This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott & White Health
        • Contact:
        • Principal Investigator:
          • Ronan Kelly, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multicancer Early Detection (MCED) cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: Up to 5 years
Particpant is alive or deceased
Up to 5 years
Cancer status
Time Frame: Up to 5 years
Presence or absence of cancer
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exact Sciences Corporation

Investigators

  • Principal Investigator: Tomasz M Beer, MD, Exact Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

September 5, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXAS 2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.

IPD Sharing Time Frame

Data will be available from 2 years and ending 4 years after publication.

IPD Sharing Access Criteria

Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary Institutional Review Board (IRB)/Ethics Committee (EC) approvals or waivers as applicable to conduct research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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