CancerNCT06589310
Falcon Real World Evidence Registry
An observational study of Cancer, run by Exact Sciences Corporation at 2 sites in United States.
Trial summary
This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Exact Sciences Multicancer Early Detection (MCED) Test
- Type of treatment
- Medical device
- How many people
- 25,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2024to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baylor Scott & White Health
Dallas, Texas, 75246
Keisha Riser, MBA, Keisha.Riser@BSWhealth.org
Ronan Kelly, M.D.
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Peter Hulick, M.D., PHulick@northshore.org
Henry (Mark) Dunnenberger, PharmD, MDunnenberger@northshore.org
About this study
Official title: 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.
Read the 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
- Being tested
- Exact Sciences Multicancer Early Detection (MCED) Test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exact Sciences Multicancer Early Detection (MCED) TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Multicancer Early Detection (MCED) cohort | Not described Receives: Device: Exact Sciences Multicancer Early Detection (MCED) Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital status
Particpant is alive or deceased
Measured: Up to 5 years
Cancer status
Presence or absence of cancer
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2024
- Primary completionAug 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exact Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz M Beer, MD, Principal investigator, Exact Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589310
- Sponsor's protocol ID
- EXAS 2022-02
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
- ClinicalTrials.gov ID
- NCT06589310
- Acronym / sponsor ID
- EXAS 2022-02
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Exact Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multicancer Early Detection (MCED) cohort | – | Device: Exact Sciences Multicancer Early Detection (MCED) Test |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exact Sciences Multicancer Early Detection (MCED) TestExact 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. | Device | Multicancer Early Detection (MCED) cohort |
Primary outcome
Vital status
Time frame: Up to 5 years
Particpant is alive or deceased
Cancer status
Time frame: Up to 5 years
Presence or absence of cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomasz M Beer, MD principal investigator
Exact Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Exact Sciences Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily Twomey (608-640-7143, etwomey@exactsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital status (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.