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Colon CancerPREEMPT CRCNCT04369053

Prevention of Colorectal Cancer Through Multiomics Blood Testing

An observational study of Colon Cancer and Rectal Cancer, run by Freenome Holdings Inc. at 148 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Colon Cancer, Rectal Cancer, Colon Neoplasm
What is being tested?
Freenome test
How many people
48,995 participants
Where
148 sitesin 2 countries
Study dates
20 May 2020to 29 Feb 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

148 sites in 2 countries.

148 sites in 2 countries

United States147 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Elligo Health Research, Inc.

    Austin, Texas, 78738

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Ascension St. Agnes Hospital

    Baltimore, Maryland, 21237

  • Delta Research Partners

    Bastrop, Louisiana, 71220

  • Margaret Mary

    Batesville, Indiana, 47006

  • Washington Gastroenterology

    Bellevue, Washington, 98004

  • St. Charles Health System, Inc

    Bend, Oregon, 97701

  • Billings Clinic

    Billings, Montana, 59101

  • Our Lady of Lourdes Hospital

    Binghamton, New York, 13905

  • Central Alabama Research

    Birmingham, Alabama, 35209

  • Alabama Oncology

    Birmingham, Alabama, 35243

  • Geisinger Bloomsburg Hospital

    Bloomsburg, Pennsylvania, 17815

  • Central Care Cancer Center

    Bolivar, Missouri, 65613

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • RecioMed Clinical Research

    Boynton Beach, Florida, 33472

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Carroll County Memorial Hospital

    Carrollton, Missouri, 64633

  • Del Sol Research Management

    Chandler, Arizona, 85224

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • MUSC

    Charleston, South Carolina, 29425

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • University of Chicago

    Chicago, Illinois, 60637

  • Precision Research Institute

    Chula Vista, California, 91910

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • John Muir Health

    Concord, California, 94520

  • Crisp Regional Hospital

    Cordele, Georgia, 31015

  • Carbon Health

    Corona, California, 92883

  • Christus Spohn Shoreline Hospital

    Corpus Christi, Texas, 78404

  • Objective Health Network

    Dayton, Ohio, 45414

  • Walgreens

    Deerfield, Illinois, 60015

  • Hillcrest Medical Research

    DeLand, Florida, 32720

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Universal Axon Clinical Research

    Doral, Florida, 33166

  • Doylestown Health

    Doylestown, Pennsylvania, 18901

  • Cancer Center of Middle Georgia (QCCA)

    Dublin, Georgia, 31021

  • Clinical Research Associates of Central PA

    DuBois, Pennsylvania, 15801

  • Miller Bioconnect

    El Cajon, California, 92021

  • Gastroenterology and Liver Institute

    Escondido, California, 92025

  • INOVA

    Fairfax, Virginia, 22031

  • Verity Research Inc

    Fairfax, Virginia, 22031

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • MacLeod Center for Cancer Treatment and Research

    Florence, South Carolina, 29506

  • McLeod Health

    Florence, South Carolina, 29506

  • ObjectiveHealth, Inc

    Franklin, Tennessee, 37067

  • Women's Cancer Network

    Fresno, California, 93710

  • SpeciCare, Inc

    Gainesville, Georgia, 30501

  • Specicare

    Gainesville, Georgia, 30501

  • Pennsylvania Cancer Specialists & Research Institute

    Gettysburg, Pennsylvania, 17325

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi, 39503

  • Hannibal Regional Hospital

    Hannibal, Missouri, 63401

  • Palmetto Research

    Hialeah, Florida, 33016

  • Clinical Research of Homestead

    Homestead, Florida, 33030

  • Horizon Clinical Research Group

    Houston, Texas, 77008

  • Oncology Consultants

    Houston, Texas, 77030

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Clinical Research Associates

    Huntsville, Alabama, 35801

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • Logan Health Research

    Kalispell, Montana, 59901

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

  • I.H.S Health, LLC

    Kissimmee, Florida, 34741

  • San Diego Clinical Trials

    La Mesa, California, 91942

  • US Digestive Health at Lancaster

    Lancaster, Pennsylvania, 17601

  • Aton Health

    Leawood, Kansas, 66211

  • Saint Joseph Cancer Center

    Lexington, Kentucky, 40509

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Urology Alliance Clinical Research

    Los Angeles, California, 90048

  • Science 37

    Los Angeles, California, 90230

  • Centra Lynchburg Hematology Oncology

    Lynchburg, Virginia, 24501

  • SSM Health-Dean Medical Group

    Madison, Wisconsin, 53715

  • Mercy Cancer Center

    Merced, California, 95340

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Ascension Columbia St. Mary's Wisconsin

    Milwaukee, Wisconsin, 53211

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407

  • University of Minnesota, School of Public Health, Environmental Health Sciences

    Minneapolis, Minnesota, 55455

  • Inspira Medical Center

    Mullica Hill, New Jersey, 08062

  • NYU

    New York, New York, 10010

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Eastern CT Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Hightower Clinical Research

    Oklahoma City, Oklahoma, 73102

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Mid Florida Hematology & Oncology Center

    Orange City, Florida, 32763

  • Silver Cross Hospital and Medical centers

    Orland Park, Illinois, 47006

  • Diverse Research Solutions

    Oxnard, California, 93030

  • Advanced Gastroenterology Associates, LLC

    Palm Harbor, Florida, 34684

  • Emerald Coast OBGYN

    Panama City, Florida, 32405

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • St Joseph University

    Paterson, New Jersey, 07503

  • Ascension Sacred Heart

    Pensacola, Florida, 32504

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19141

  • Circle Clinical Research

    Pierre, South Dakota, 57104

  • Pomona Valley Hospital Medical Center/Cancer Care Center

    Pomona, California, 91767

  • NY Cancer & Blood Specialists

    Port Jefferson Station, New York, 11776

  • United Medical Research

    Port Orange, Florida, 32127

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • Oregon Health and Science University

    Portland, Oregon, 97201

  • Wakemed

    Raleigh, North Carolina, 27610

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Cancer Care Specialists Reno

    Reno, Nevada, 93710

  • Ascension Providence Rochester Hospital

    Rochester Hills, Michigan, 48309

  • Carolina Blood and Cancer Care Associates

    Rock Hill, South Carolina, 29732

  • Rockford Gastroenterology

    Rockford, Illinois, 61107

  • Northwest Oncology & Hematology

    Rolling Meadows, Illinois, 60008

  • Covenant HealthCare

    Saginaw, Michigan, 48604

  • St. Mary's Medical Center

    San Francisco, California, 94117

  • Dominican Hospital Dignity Health

    Santa Cruz, California, 94520

  • Donald Guthrie Foundation

    Sayre, Pennsylvania, 18840

  • Guthrie Medical Group

    Sayre, Pennsylvania, 18840

  • Honor Health

    Scottsdale, Arizona, 85258

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71103

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Objective Health Network (Digestive Research Alliance of Michiana, LLC)

    South Bend, Indiana, 46635

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • Springfield Clinic, LLP

    Springfield, Illinois, 62702

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Stockton Hematology Oncology

    Stockton, California, 95204

  • Northwest Medical Specialties (QCCA)

    Tacoma, Washington, 98405

  • Charter Research

    The Villages, Florida, 32162

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Del Sol Research Management,

    Tucson, Arizona, 85710

  • Christus Trinity Mother Frances Health System

    Tyler, Texas, 75702

  • Inspira Medical Center Vineland

    Vineland, New Jersey, 08360

  • White Plains Hospital

    White Plains, New York, 10601

  • Ascension Via Christi Hospital, Wichita

    Wichita, Kansas, 67214

  • Ascension Via Christi Wichita

    Wichita, Kansas, 67214

  • Trial Management Associates

    Wilmington, North Carolina, 28403

  • Winona Health System

    Winona, Minnesota, 55987

  • USDH Clinical Research

    Wyomissing, Pennsylvania, 19160

  • US Digestive Health at Wyomissing

    Wyomissing, Pennsylvania, 19610

  • Cancer Care Associates of York (QCCA)

    York, Pennsylvania, 17403

Other trials in United States

Canada1 site

  • Forzani and MacPhail Colon Cancer Screening Centre

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Freenome test
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms, Colonic Diseases, Colonic Polyps, Colorectal Neoplasms, Polyps, Adenoma, Rectal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Freenome testDiagnostic test

    Also called Single Group Assignment

    Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity for Colorectal Cancer

    Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer

    Measured: 90 days

  2. Specificity for Advanced Colorectal Neoplasia

    Proportion of participants with a negative test result among those who had non-advanced precancerous lesions or negative findings (non-neoplastic or no findings)

    Measured: 90 days

  3. Negative Predictive Value for Advanced Colorectal Neoplasia

    Proportion of participants with a diagnosis of non-advanced precancerous lesions or negative findings (non-neoplastic or no findings) among those who had a negative test result

    Measured: 90 days

  4. Positive Predictive Value for Advanced Colorectal Neoplasia

    Proportion of participants with a diagnosis of colorectal cancer or advanced precancerous lesions among those who had a positive test result

    Measured: 90 days

Secondary outcomes (1)

  1. Sensitivity for Advanced Precancerous Lesion

    Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2020
  2. Study start20 May 2020
  3. Primary completion29 Feb 2024
  4. Study completion29 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48,995 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04369053
Sponsor's protocol ID
FRNM-004
Acronym
PREEMPT CRC
Status last verified
Dec 2025
First submitted
27 Apr 2020
Last updated
26 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shaukat A, Burke CA, Chan AT, Grady WM, Gupta S, Katona BW, Ladabaum U, Liang PS, Liu JJ, Putcha G, Robertson DJ, Schoen RE, Meng Z, Piscitello A, Sun CK, Xu C, Lin CJ, Lee LC, Baldo L, Levin TR; PREEMPT CRC Investigators. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025 Jul 1;334(1):56-63. doi: 10.1001/jama.2025.7515.

    PubMed 40455622

  • Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.

    PubMed 40207404

  • Mills K, Figueroa F, Knight R, Ekpo E, Lee LC, Baldo L, Xu C, Wang S, Adelman RM, Pemu P, Levin T, Shaukat A, Liu JJ. Fact or Myth? Black Patients Do Not Want to Participate in Clinical Trials. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00826. doi: 10.14309/ctg.0000000000000826.

    PubMed 39878425

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Cancer and Rectal Cancer, run by Freenome Holdings Inc. at 148 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity for Colorectal Cancer (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04369053, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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