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NCT06589310 | RECRUITING | Cancer

Falcon Real World Evidence Registry
Sponsor:

Exact Sciences Corporation

Brief Summary:

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

Condition or disease

Cancer

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 25000 participants
Official Title : Falcon - The Exact Sciences Multicancer Early Detection (MCED) Real World Evidence (RWE) Registry
Actual Study Start Date : 2024-08-01
Estimated Primary Completion Date : 2030-08
Estimated Study Completion Date : 2031-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Falcon Real World Evidence Registry

Location Details

NCT06589310

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Illinois

Endeavor Health

Evanston, Illinois, United States, 60201

RECRUITING

United States, Texas

Baylor Scott & White Health

Dallas, Texas, United States, 75246