Falcon Real World Evidence Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exact Sciences Multicancer Early Detection (MCED) Test.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
Overview
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
- 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.
Primary outcome measures
- Vital status [Time frame: Up to 5 years]
- Cancer status [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Endeavor Health — Evanston
- Baylor Scott & White Health — Dallas
Identifiers
NCT: NCT06589310 · EXAS 2022-02