Falcon Real World Evidence Registry

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06589310

Enrollment

25000

Registered

2024-09-19

Start date

2024-08-01

Completion date

2031-01-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief 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.

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy 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

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTEmily Twomey

etwomey@exactsciences.com608-640-7143

PRINCIPAL_INVESTIGATORTomasz M Beer, MD

Exact Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026