Falcon Real World Evidence Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2031-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Multicancer Early Detection (MCED) cohort

Exact Sciences Multicancer Early Detection (MCED) Test

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes