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Prevention of Colorectal Cancer Through Multiomics Blood Testing | Clinical Trials | Clareo Health

COMPLETED

Prevention of Colorectal Cancer Through Multiomics Blood Testing

NCT04369053•Freenome Holdings Inc.

Summary

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Detailed Description

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Eligibility

Age

45 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. 45-85 years of age
•2. Willing to undergo a standard-of-care screening colonoscopy
•3. Able and willing to provide a blood sample
•4. Able and willing to sign informed consent

Exclusion Criteria

•1. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
•2. Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation
•3. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
•4. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy

Locations (148)

Central Alabama Research

Birmingham, Alabama, United States

Alabama Oncology

Birmingham, Alabama, United States

Clinical Research Associates

Huntsville, Alabama, United States

Del Sol Research Management

Chandler, Arizona, United States

Honor Health

Scottsdale, Arizona, United States

Del Sol Research Management,

Tucson, Arizona, United States

Preferred Research Partners

Little Rock, Arkansas, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Precision Research Institute

Chula Vista, California, United States

John Muir Health

Concord, California, United States

Key Dates

Start Date

May 20, 2020

Primary Completion Date

February 29, 2024

Completion Date

February 29, 2024

Last Updated

December 26, 2025

Enrollment

48,995

ACTUAL participants

Conditions

Colon CancerRectal CancerColon NeoplasmColon DiseasesColon LesionColon PolypColorectal CancerPolypAdenomaRectal DiseasesGastrointestinal Tract Cancers

Interventions

Freenome test

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Prevention of Colorectal Cancer Through Multiomics Blood Testing

Inclusion Criteria

Exclusion Criteria

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