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Recruiting

NCT Number: NCT06589310

Falcon Real World Evidence Registry

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

Recruiting

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endeavor Health, Evanston, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exact Sciences Multicancer Early Detection (MCED) Test

Device

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 outcomes

  1. Vital status

    Time frame: Up to 5 years

    Particpant is alive or deceased

  2. Cancer status

    Time frame: Up to 5 years

    Presence or absence of cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Deb Kettner-Sieber

CONTACT

[email protected]

608-982-6734

Sponsors and collaborators

Lead sponsor

Exact Sciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Sep 19, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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