Falcon Real World Evidence Registry

Last updated: December 10, 2024
Sponsor: Exact Sciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

Exact Sciences Multicancer Early Detection (MCED) Test

Clinical Study ID

NCT06589310
EXAS 2022-02
  • Ages 50-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancyin the previous three years or current suspicion of cancer and/or in activetreatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery

Study Design

Total Participants: 25000
Treatment Group(s): 1
Primary Treatment: Exact Sciences Multicancer Early Detection (MCED) Test
Phase:
Study Start date:
August 01, 2024
Estimated Completion Date:
January 31, 2031

Study 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.

Connect with a study center

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Active - Recruiting

  • Baylor Scott & White Health

    Dallas, Texas 75246
    United States

    Active - Recruiting

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