Blood test may spot colon cancer early, study shows

NCT ID NCT04369053

Diagnosis Sponsor: Freenome Holdings Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new blood test designed to find colorectal cancer early in people at average risk. Nearly 49,000 adults aged 45-85 gave a blood sample before their routine colonoscopy. The goal was to see how well the blood test could detect cancer and advanced growths compared to the standard colonoscopy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

48,995 people

The number who actually took part.

Started

May 2020

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

45 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

adenoma colon carcinoma colonic disorder colonic neoplasm colorectal cancer colorectal neoplasm digestive system cancer digestive system neoplasm polyp polyp of colon rectal cancer rectal disorder rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adenoma Colon cancer Colon diseases Colon lesion Colon neoplasm Colon polyp Colorectal cancer Gastrointestinal tract cancers Polyp Rectal cancer Rectal diseases

Contacts and locations

Locations

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34684, United States
Advanced Research Institute

Ogden, Utah, 84405, United States
Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States
Alabama Oncology

Birmingham, Alabama, 35243, United States
Allina Health Cancer Institute

Minneapolis, Minnesota, 55407, United States
Altru Health System

Grand Forks, North Dakota, 58201, United States
Ascension Columbia St. Mary's Wisconsin

Milwaukee, Wisconsin, 53211, United States
Ascension Providence Rochester Hospital

Rochester Hills, Michigan, 48309, United States
Ascension Sacred Heart

Pensacola, Florida, 32504, United States
Ascension St. Agnes Hospital

Baltimore, Maryland, 21237, United States
Ascension Via Christi Hospital, Wichita

Wichita, Kansas, 67214, United States
Ascension Via Christi Wichita

Wichita, Kansas, 67214, United States
Asheville Gastroenterology Associates

Asheville, North Carolina, 28801, United States
Aton Health

Leawood, Kansas, 66211, United States
Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States
Billings Clinic

Billings, Montana, 59101, United States
Cancer Care Associates of York (QCCA)

York, Pennsylvania, 17403, United States
Cancer Care Specialists Reno

Reno, Nevada, 93710, United States
Cancer Center of Middle Georgia (QCCA)

Dublin, Georgia, 31021, United States
Cape Cod Hospital

Hyannis, Massachusetts, 02601, United States
Carbon Health

Corona, California, 92883, United States
Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States
Carroll County Memorial Hospital

Carrollton, Missouri, 64633, United States
Centra Lynchburg Hematology Oncology

Lynchburg, Virginia, 24501, United States
Central Alabama Research

Birmingham, Alabama, 35209, United States
Central Care Cancer Center

Bolivar, Missouri, 65613, United States
Charter Research

The Villages, Florida, 32162, United States
Christus Spohn Shoreline Hospital

Corpus Christi, Texas, 78404, United States
Christus Trinity Mother Frances Health System

Tyler, Texas, 75702, United States
Circle Clinical Research

Pierre, South Dakota, 57104, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Clinical Research Associates

Huntsville, Alabama, 35801, United States
Clinical Research Associates of Central PA

DuBois, Pennsylvania, 15801, United States
Clinical Research of Homestead

Homestead, Florida, 33030, United States
Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States
Covenant HealthCare

Saginaw, Michigan, 48604, United States
Crisp Regional Hospital

Cordele, Georgia, 31015, United States
Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States
Del Sol Research Management

Chandler, Arizona, 85224, United States
Del Sol Research Management,

Tucson, Arizona, 85710, United States
Delta Research Partners

Bastrop, Louisiana, 71220, United States
Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States
Diverse Research Solutions

Oxnard, California, 93030, United States
Dominican Hospital Dignity Health

Santa Cruz, California, 94520, United States
Donald Guthrie Foundation

Sayre, Pennsylvania, 18840, United States
Doylestown Health

Doylestown, Pennsylvania, 18901, United States
Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States
Elligo Health Research, Inc.

Austin, Texas, 78738, United States
Emerald Coast OBGYN

Panama City, Florida, 32405, United States
Forzani and MacPhail Colon Cancer Screening Centre

Calgary, Alberta, T2N 4Z6, Canada
Gabrail Cancer Center Research

Canton, Ohio, 44718, United States
Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, 06606, United States
Gastroenterology Associates of Tidewater

Chesapeake, Virginia, 23320, United States
Gastroenterology and Liver Institute

Escondido, California, 92025, United States
Geisinger Bloomsburg Hospital

Bloomsburg, Pennsylvania, 17815, United States
Guthrie Medical Group

Sayre, Pennsylvania, 18840, United States
Hannibal Regional Hospital

Hannibal, Missouri, 63401, United States
Henry Ford Health

Detroit, Michigan, 48202, United States
Highlands Oncology Group

Springdale, Arkansas, 72762, United States
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hightower Clinical Research

Oklahoma City, Oklahoma, 73102, United States
Hillcrest Medical Research

DeLand, Florida, 32720, United States
Honor Health

Scottsdale, Arizona, 85258, United States
Horizon Clinical Research Group

Houston, Texas, 77008, United States
I.H.S Health, LLC

Kissimmee, Florida, 34741, United States
INOVA

Fairfax, Virginia, 22031, United States
Inspira Medical Center

Mullica Hill, New Jersey, 08062, United States
Inspira Medical Center Vineland

Vineland, New Jersey, 08360, United States
Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States
John Muir Health

Concord, California, 94520, United States
Logan Health Research

Kalispell, Montana, 59901, United States
Louisiana Research Center

Shreveport, Louisiana, 71105, United States
Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States
Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States
MUSC

Charleston, South Carolina, 29425, United States
MacLeod Center for Cancer Treatment and Research

Florence, South Carolina, 29506, United States
Margaret Mary

Batesville, Indiana, 47006, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
McLeod Health

Florence, South Carolina, 29506, United States
Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States
Memorial Hospital at Gulfport

Gulfport, Mississippi, 39503, United States
Mercy Cancer Center

Merced, California, 95340, United States
Mercy Medical Center

Baltimore, Maryland, 21202, United States
Mid Florida Hematology & Oncology Center

Orange City, Florida, 32763, United States
Miller Bioconnect

El Cajon, California, 92021, United States
Morehouse School of Medicine

Atlanta, Georgia, 30310, United States
NY Cancer & Blood Specialists

Port Jefferson Station, New York, 11776, United States
NYU

New York, New York, 10010, United States
New Orleans Research Institute

Metairie, Louisiana, 70006, United States
North Kansas City Hospital

North Kansas City, Missouri, 64116, United States
Northwest Medical Specialties (QCCA)

Tacoma, Washington, 98405, United States
Northwest Oncology & Hematology

Rolling Meadows, Illinois, 60008, United States
Objective Health Network

Dayton, Ohio, 45414, United States
Objective Health Network (Digestive Research Alliance of Michiana, LLC)

South Bend, Indiana, 46635, United States
ObjectiveHealth, Inc

Franklin, Tennessee, 37067, United States
Oncology Consultants

Houston, Texas, 77030, United States
Oregon Health & Science University

Portland, Oregon, 97201, United States
Oregon Health and Science University

Portland, Oregon, 97201, United States
Our Lady of Lourdes Hospital

Binghamton, New York, 13905, United States
Palmetto Research

Hialeah, Florida, 33016, United States
Pennsylvania Cancer Specialists & Research Institute

Gettysburg, Pennsylvania, 17325, United States
Pomona Valley Hospital Medical Center/Cancer Care Center

Pomona, California, 91767, United States
Precision Research Institute

Chula Vista, California, 91910, United States
Preferred Research Partners

Little Rock, Arkansas, 72211, United States
Quality Clinical Research

Omaha, Nebraska, 68114, United States
RecioMed Clinical Research

Boynton Beach, Florida, 33472, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Rockford Gastroenterology

Rockford, Illinois, 61107, United States
SSM Health-Dean Medical Group

Madison, Wisconsin, 53715, United States
Saint Joseph Cancer Center

Lexington, Kentucky, 40509, United States
San Diego Clinical Trials

La Mesa, California, 91942, United States
Science 37

Los Angeles, California, 90230, United States
Silver Cross Hospital and Medical centers

Orland Park, Illinois, 47006, United States
SpeciCare, Inc

Gainesville, Georgia, 30501, United States
Specicare

Gainesville, Georgia, 30501, United States
Springfield Clinic, LLP

Springfield, Illinois, 62702, United States
St Joseph University

Paterson, New Jersey, 07503, United States
St. Charles Health System, Inc

Bend, Oregon, 97701, United States
St. Mary's Medical Center

San Francisco, California, 94117, United States
Stamford Hospital

Stamford, Connecticut, 06902, United States
Stockton Hematology Oncology

Stockton, California, 95204, United States
Temple University

Philadelphia, Pennsylvania, 19140, United States
The Jackson Clinic

Jackson, Tennessee, 38305, United States
The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States
The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19141, United States
Torrance Memorial Physician Network - Cancer Care

Torrance, California, 90505, United States
Trial Management Associates

Wilmington, North Carolina, 28403, United States
US Digestive Health at Lancaster

Lancaster, Pennsylvania, 17601, United States
US Digestive Health at Wyomissing

Wyomissing, Pennsylvania, 19610, United States
USDH Clinical Research

Wyomissing, Pennsylvania, 19160, United States
United Medical Research

Port Orange, Florida, 32127, United States
Universal Axon Clinical Research

Doral, Florida, 33166, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University of Chicago

Chicago, Illinois, 60637, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Minnesota, School of Public Health, Environmental Health Sciences

Minneapolis, Minnesota, 55455, United States
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
Urology Alliance Clinical Research

Los Angeles, California, 90048, United States
Verity Research Inc

Fairfax, Virginia, 22031, United States
Wake Research Associates

Raleigh, North Carolina, 27612, United States
Wakemed

Raleigh, North Carolina, 27610, United States
Walgreens

Deerfield, Illinois, 60015, United States
Washington Gastroenterology

Bellevue, Washington, 98004, United States
White Plains Hospital

White Plains, New York, 10601, United States
Winona Health System

Winona, Minnesota, 55987, United States
Women's Cancer Network

Fresno, California, 93710, United States

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