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NCT06589310RecruitingAccepts Healthy Volunteers

Falcon Real World Evidence Registry

Exact Sciences Corporation

Start Date

8/1/2024

Completion Date

1/1/2031

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.

Eligibility Criteria

Age Range: 50 years to 80 years

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

Interventions

DEVICE

Exact Sciences Multicancer Early Detection (MCED) Test

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Conditions

Cancer

Locations

Endeavor Health

Evanston, Illinois 60201

United States

Baylor Scott & White Health

Dallas, Texas 75246

United States