Falcon Real World Evidence Registry
Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
1 other identifier
observational
25,000
1 country
2
Brief Summary
This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2031
May 31, 2025
May 1, 2025
6 years
August 19, 2024
May 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Vital status
Particpant is alive or deceased
Up to 5 years
Cancer status
Presence or absence of cancer
Up to 5 years
Study Arms (1)
Multicancer Early Detection (MCED) cohort
Interventions
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.
Eligibility Criteria
Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Endeavor Health
Evanston, Illinois, 60201, United States
Baylor Scott & White Health
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Tomasz M Beer, MD
Exact Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2024
First Posted
September 19, 2024
Study Start
August 1, 2024
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
January 1, 2031
Last Updated
May 31, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available from 2 years and ending 4 years after publication.
- 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.
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.