Status:

COMPLETED

Prevention of Colorectal Cancer Through Multiomics Blood Testing

Lead Sponsor:

Freenome Holdings Inc.

Conditions:

Colon Cancer

Rectal Cancer

Eligibility:

All Genders

45-85 years

Brief 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 partic...

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...

Eligibility Criteria

Inclusion

  • Key Inclusion Criteria
  • 45-85 years of age
  • Willing to undergo a standard-of-care screening colonoscopy
  • Able and willing to provide a blood sample
  • Able and willing to sign informed consent
  • Key Exclusion Criteria
  • Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
  • 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
  • A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 20 2020

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    February 29 2024

    Estimated Enrollment :

    48995 Patients enrolled

    Trial Details

    Trial ID

    NCT04369053

    Start Date

    May 20 2020

    End Date

    February 29 2024

    Last Update

    December 26 2025

    Active Locations (148)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 37 (148 locations)

    1

    Central Alabama Research

    Birmingham, Alabama, United States, 35209

    2

    Alabama Oncology

    Birmingham, Alabama, United States, 35243

    3

    Clinical Research Associates

    Huntsville, Alabama, United States, 35801

    4

    Del Sol Research Management

    Chandler, Arizona, United States, 85224