Prevention of Colorectal Cancer Through Multiomics Blood Testing (PREEMPT CRC)

February 26, 2024 updated by: Freenome Holdings Inc.
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Cleveland Clinic Abu Dhabi
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group LLC
      • Birmingham, Alabama, United States, 35294
        • University of Alabama At Birmingham
      • Birmingham, Alabama, United States, 35233
        • Birmingham VA Medical Center - Alabama
      • Homewood, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Advanced Gastroenterology PC
      • Chandler, Arizona, United States, 85224
        • Southeast Valley Gastro (SEVG)
    • California
      • Anaheim, California, United States, 92801
        • Associated Gastroenterology Medical Group
      • Beverly Hills, California, United States, 90212
        • Matrix Clinical Research
      • Chula Vista, California, United States, 91910
        • Precision Research Institute, LLC
      • Covina, California, United States, 91722
        • Citrus Valley Gastroenterology
      • Downey, California, United States, 90242
        • Kaiser Permanente Southern California
      • Garden Grove, California, United States, 92840
        • Paragon Rx Clinical - Garden Grove
      • Lancaster, California, United States, 93534
        • Gastro Care Institute
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90094
        • Science 37
      • Mission Viejo, California, United States, 92691
        • St. Joseph Heritage Healthcare
      • Murrieta, California, United States, 92562
        • Inland Empire GI
      • Northridge, California, United States, 91325
        • Los Angeles Gastroenterology Institute
      • Oakland, California, United States, 94612
        • East Bay Center for Digestive Health
      • Orange, California, United States, 92868
        • Knowledge Research Center
      • Sacramento, California, United States, 95816
        • Sutter Institute for Medical Research
      • San Diego, California, United States, 92103
        • University of California San Diego Medical Center
      • San Diego, California, United States, 92114
        • Precision Research Institute, LLC
      • San Francisco, California, United States, 94115
        • UCSF Mount Zion Medical Center
      • Santa Ana, California, United States, 92703
        • Paragon Rx Clinical - Santa Ana
      • Santa Monica, California, United States, 90404
        • Digestive Health Associates
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Northern California
      • Walnut Creek, California, United States, 94598
        • Clinical Research of California LLC
    • Connecticut
      • Greenwich, Connecticut, United States, 06831
        • The Center for Gastrointestinal Medicine of Fairfield and Westchester, P.C
      • Prospect, Connecticut, United States, 06712
        • Naugatuck Valley GI Consultants
    • Delaware
      • Newark, Delaware, United States, 19713
        • Delaware Center for Digestive Care
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Veterans Affairs Medical Center
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Bay Pines VA Healthcare System
      • Boca Raton, Florida, United States, 33433
        • Hillel Cohen, MD
      • Doral, Florida, United States, 33166
        • Universal Axon Clinical Research
      • Hialeah, Florida, United States, 33016
        • Palmetto Research, LLC
      • Hollywood, Florida, United States, 33021
        • The Center for Gastrointestinal Disorders
      • Jacksonville, Florida, United States, 32256
        • ENCORE
      • Kissimmee, Florida, United States, 34744
        • Central Florida Gastro Research
      • Kissimmee, Florida, United States, 34741
        • IHS Health
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Ocala, Florida, United States, 34471
        • Ocala GI Research
      • Saint Augustine, Florida, United States, 32086
        • St. Johns Center for Clinical Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse
      • Atlanta, Georgia, United States, 30342
        • Metro Atlanta Gastroenterology, LLC
      • Augusta, Georgia, United States, 30912
        • Augusta University
      • Columbus, Georgia, United States, 31904
        • IACT Health
      • Conyers, Georgia, United States, 30322
        • Emory University School Of Medicine
      • Evans, Georgia, United States, 30809
        • Gastroenterology Consultants of Augusta
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
      • Roswell, Georgia, United States, 30076
        • Pramukh Clinical Research
      • Savannah, Georgia, United States, 31405
        • Gastroenterology Consultants of Savannah, PC
      • Waycross, Georgia, United States, 31501
        • Southeast Georgia Gastroenterology, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Downers Grove, Illinois, United States, 60515
        • Digestive Health Services, a Division of GI Partners of Illinios
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
      • Hines, Illinois, United States, 60141
        • Edward Hines, Jr. VA Hospital
      • Naperville, Illinois, United States, 60540
        • Suburban Gastroenterology
      • New Lenox, Illinois, United States, 60451
        • Digestive Diseases Consultants of Kankakee
      • Oak Lawn, Illinois, United States, 60453
        • GI Partners of Illinois - Southwest Gastroenerology
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic, Llp
    • Indiana
      • Muncie, Indiana, United States, 47304
        • American Health Network of Indiana, LLC
      • South Bend, Indiana, United States, 46635
        • Digestive Research Alliance of Michiana
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
      • Wichita, Kansas, United States, 67226
        • Kansas Gastroenterology, LLC
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Tri-State Gastroenterology Associates, PSC
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Delta Research Partners - Bastrop
      • Hammond, Louisiana, United States, 70403
        • Northlake Gastroenterology Associates
      • Monroe, Louisiana, United States, 71201
        • Delta Research Parnters - Monroe
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Woodholme Gastroenterology Associates
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Framingham, Massachusetts, United States, 01702
        • Greater Boston Gastroenterology
      • South Weymouth, Massachusetts, United States, 02190
        • South Suburban Gastroenterology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Gastroenterology Associates of Mississippi
      • Flowood, Mississippi, United States, 39232
        • Gastrointestinal Associates
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Gastrointestinal Associates
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
      • Washington, Missouri, United States, 63090
        • Mercy Washington
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • LV Gastroenterology Associates
      • North Las Vegas, Nevada, United States, 89086
        • VA Southern Nevada
      • Reno, Nevada, United States, 89511
        • Advanced Research Institute
      • Reno, Nevada, United States, 89502
        • VA Sierra Nevada
    • New Jersey
      • Dover, New Jersey, United States, 07801
        • Gastroenterology Associates in NJ
      • Florham Park, New Jersey, United States, 07932
        • AIG Digestive Disease Research
      • Hillsborough, New Jersey, United States, 08844
        • Digestive Healthcare Center
      • North Bergen, New Jersey, United States, 07047
        • Gastroenterology Medical Associates
      • Ocean City, New Jersey, United States, 07712
        • Dr. Howard N. Guss and Dr. Gagan Beri
      • Princeton, New Jersey, United States, 08540
        • Princeton GI Associates
      • Teaneck, New Jersey, United States, 07666
        • Teaneck Gastroenterology Associates
      • Toms River, New Jersey, United States, 08755
        • Ocean Family Gastroenterology
      • Union, New Jersey, United States, 07083
        • Advanced Gasteroenterology Group
      • Union, New Jersey, United States, 07083
        • Center for Digestive Diseases
    • New York
      • Albany, New York, United States, 12208
        • Samuel S. Stratton VA Medical Center
      • Brooklyn, New York, United States, 11234
        • Sam Moskowitz, MD
      • Camillus, New York, United States, 13031
        • Associated Gastroenterologists of Central NY
      • Great Neck, New York, United States, 11023
        • North Shore Gastroenterology Associates
      • Lawrence, New York, United States, 11559
        • South Island Gastro
      • Manorville, New York, United States, 11949
        • Mark Coronel, MD
      • New City, New York, United States, 10956
        • Gastrointestinal Associates of Rockland
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research, PLLC
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • NYU Grossman School of Medicine
      • New York, New York, United States, 10065
        • Cornell
      • Syracuse, New York, United States, 13210
        • Syracuse Gastroenterological Associates, PC
      • Valley Stream, New York, United States, 11581
        • GastroCare LI
      • Wantagh, New York, United States, 11793
        • Long Island Gastrointestinal Specialist
      • West Nyack, New York, United States, 10994
        • William S. Silver MD & Eric L. Tatar MD PC.
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Gastro Associates
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Clinic
      • Raleigh, North Carolina, United States, 27607
        • Carolina's GI Research, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem, LLC
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Center Medical Arts
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Cincinnati GI
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation - Central
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC
      • Springboro, Ohio, United States, 45066
        • DSI Research
    • Oregon
      • Bend, Oregon, United States, 97701
        • Summit Medical Group Oregon - BMC
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic, P.C.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Eastern Pennsylvania GI & Liver Specialist
      • Altoona, Pennsylvania, United States, 16602
        • Blair Gastroenterology Associates
      • Beaver Falls, Pennsylvania, United States, 15010
        • Valley Gastroenterology Associates
      • Camp Hill, Pennsylvania, United States, 17011
        • Susquehanna Research Group, LLC
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19014
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Digestive Diseases Center GAS
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Southeast Medical Research II, LLC
      • Greenville, South Carolina, United States, 29601
        • Gastroenterology Associates, PA
      • Greenwood, South Carolina, United States, 29646
        • Digestive Disease Research Center
      • West Columbia, South Carolina, United States, 29169
        • Consultants in GI
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • ARCare Center of Clinical Research
      • Johnson City, Tennessee, United States, 37604
        • Gastrointestinal Associates of NorthEast Tenn
      • Kingsport, Tennessee, United States, 37663
        • Tri-Cities Gastroenterology
      • Knoxville, Tennessee, United States, 37909
        • Gastroenterology Associates, PC
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Union City, Tennessee, United States, 38261
        • Advanced Gastroenterology
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology
      • Arlington, Texas, United States, 76018
        • Gastroenterology Practice Associates
      • Cypress, Texas, United States, 77429
        • Mohan, Uma Yanamadala
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Ertan Digestive Disease Center
      • Houston, Texas, United States, 77034
        • Gastroenterology Consults
      • Houston, Texas, United States, 77070
        • Hope Digestive and Liver Disease Clinic of Houston
      • Houston, Texas, United States, 77080
        • Panamericana Family Medicine Clinic
      • McAllen, Texas, United States, 78503
        • Rio Grande Gastroenterology
      • Pasadena, Texas, United States, 77505
        • Digestive System Healthcare
      • Pasadena, Texas, United States, 77504
        • Gastroenterology Consultants
      • Shenandoah, Texas, United States, 77384
        • Gastroenterology Partners of North Houston
      • Tomball, Texas, United States, 77375
        • Texas Gastro Consultants
      • Tyler, Texas, United States, 75702
        • Texas Oncology
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler
      • Wichita Falls, Texas, United States, 76301
        • Digestive Health Research of North Texas
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
      • Salt Lake City, Utah, United States, 84119
        • Intermountain
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists, Ltd.
      • Roanoke, Virginia, United States, 24014
        • Gastroenterology Consultants of SW Virginia
    • Washington
      • Seattle, Washington, United States, 98195
        • UW Medical Center
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology - Tacoma Clinic
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • GastroIntestinal Associates, S.C.
    • Wyoming
      • Casper, Wyoming, United States, 82601
        • Gastroenterology Associates of Wyoming

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy.

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity for CRC of the Freenome test
Time Frame: 90 days
90 days
Specificity of the Freenome test
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Freenome Holdings Inc.

Investigators

  • Principal Investigator: Aasma Shaukat, MD MPH, University of Minnesota
  • Principal Investigator: Theodore R Levin, MD, The Permanente Medical Group
  • Study Chair: Lance Baldo, MD, Freenome Holdings Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2020

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRNM-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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