Prevention of Colorectal Cancer Through Multiomics Blood Testing
NCT ID: NCT04369053
Last Updated: 2025-12-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
48995 participants
OBSERVATIONAL
2020-05-20
2024-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Freenome test
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
45 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Freenome Holdings Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aasma Shaukat, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Theodore R Levin, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente Division of Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Carbon Health
Corona, California, United States
Miller Bioconnect
El Cajon, California, United States
Gastroenterology and Liver Institute
Escondido, California, United States
Women's Cancer Network
Fresno, California, United States
San Diego Clinical Trials
La Mesa, California, United States
Urology Alliance Clinical Research
Los Angeles, California, United States
Science 37
Los Angeles, California, United States
Mercy Cancer Center
Merced, California, United States
Diverse Research Solutions
Oxnard, California, United States
Pomona Valley Hospital Medical Center/Cancer Care Center
Pomona, California, United States
St. Mary's Medical Center
San Francisco, California, United States
Dominican Hospital Dignity Health
Santa Cruz, California, United States
Stockton Hematology Oncology
Stockton, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States
Stamford Hospital
Stamford, Connecticut, United States
RecioMed Clinical Research
Boynton Beach, Florida, United States
Hillcrest Medical Research
DeLand, Florida, United States
Universal Axon Clinical Research
Doral, Florida, United States
Palmetto Research
Hialeah, Florida, United States
Clinical Research of Homestead
Homestead, Florida, United States
I.H.S Health, LLC
Kissimmee, Florida, United States
Mid Florida Hematology & Oncology Center
Orange City, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
Emerald Coast OBGYN
Panama City, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
United Medical Research
Port Orange, Florida, United States
Charter Research
The Villages, Florida, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Crisp Regional Hospital
Cordele, Georgia, United States
Cancer Center of Middle Georgia (QCCA)
Dublin, Georgia, United States
SpeciCare, Inc
Gainesville, Georgia, United States
Specicare
Gainesville, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Walgreens
Deerfield, Illinois, United States
Silver Cross Hospital and Medical centers
Orland Park, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Rockford Gastroenterology
Rockford, Illinois, United States
Northwest Oncology & Hematology
Rolling Meadows, Illinois, United States
Springfield Clinic, LLP
Springfield, Illinois, United States
Margaret Mary
Batesville, Indiana, United States
Objective Health Network (Digestive Research Alliance of Michiana, LLC)
South Bend, Indiana, United States
Aton Health
Leawood, Kansas, United States
Ascension Via Christi Hospital, Wichita
Wichita, Kansas, United States
Ascension Via Christi Wichita
Wichita, Kansas, United States
Saint Joseph Cancer Center
Lexington, Kentucky, United States
Delta Research Partners
Bastrop, Louisiana, United States
New Orleans Research Institute
Metairie, Louisiana, United States
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Louisiana Research Center
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Ascension St. Agnes Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health
Detroit, Michigan, United States
Ascension Providence Rochester Hospital
Rochester Hills, Michigan, United States
Covenant HealthCare
Saginaw, Michigan, United States
Allina Health Cancer Institute
Minneapolis, Minnesota, United States
University of Minnesota, School of Public Health, Environmental Health Sciences
Minneapolis, Minnesota, United States
Winona Health System
Winona, Minnesota, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Carroll County Memorial Hospital
Carrollton, Missouri, United States
Hannibal Regional Hospital
Hannibal, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
North Kansas City, Missouri, United States
Billings Clinic
Billings, Montana, United States
Logan Health Research
Kalispell, Montana, United States
Quality Clinical Research
Omaha, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Cancer Care Specialists Reno
Reno, Nevada, United States
Inspira Medical Center
Mullica Hill, New Jersey, United States
St Joseph University
Paterson, New Jersey, United States
Inspira Medical Center Vineland
Vineland, New Jersey, United States
Our Lady of Lourdes Hospital
Binghamton, New York, United States
NYU
New York, New York, United States
NY Cancer & Blood Specialists
Port Jefferson Station, New York, United States
White Plains Hospital
White Plains, New York, United States
Asheville Gastroenterology Associates
Asheville, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
Wakemed
Raleigh, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
Altru Health System
Grand Forks, North Dakota, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Objective Health Network
Dayton, Ohio, United States
Hightower Clinical Research
Oklahoma City, Oklahoma, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
St. Charles Health System, Inc
Bend, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Geisinger Bloomsburg Hospital
Bloomsburg, Pennsylvania, United States
Doylestown Health
Doylestown, Pennsylvania, United States
Clinical Research Associates of Central PA
DuBois, Pennsylvania, United States
Pennsylvania Cancer Specialists & Research Institute
Gettysburg, Pennsylvania, United States
US Digestive Health at Lancaster
Lancaster, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Donald Guthrie Foundation
Sayre, Pennsylvania, United States
Guthrie Medical Group
Sayre, Pennsylvania, United States
USDH Clinical Research
Wyomissing, Pennsylvania, United States
US Digestive Health at Wyomissing
Wyomissing, Pennsylvania, United States
Cancer Care Associates of York (QCCA)
York, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
MUSC
Charleston, South Carolina, United States
MacLeod Center for Cancer Treatment and Research
Florence, South Carolina, United States
McLeod Health
Florence, South Carolina, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States
Circle Clinical Research
Pierre, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
ObjectiveHealth, Inc
Franklin, Tennessee, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
The Jackson Clinic
Jackson, Tennessee, United States
Elligo Health Research, Inc.
Austin, Texas, United States
Christus Spohn Shoreline Hospital
Corpus Christi, Texas, United States
Horizon Clinical Research Group
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Christus Trinity Mother Frances Health System
Tyler, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States
INOVA
Fairfax, Virginia, United States
Verity Research Inc
Fairfax, Virginia, United States
Centra Lynchburg Hematology Oncology
Lynchburg, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Washington Gastroenterology
Bellevue, Washington, United States
Northwest Medical Specialties (QCCA)
Tacoma, Washington, United States
SSM Health-Dean Medical Group
Madison, Wisconsin, United States
Ascension Columbia St. Mary's Wisconsin
Milwaukee, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Forzani and MacPhail Colon Cancer Screening Centre
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FRNM-004
Identifier Type: -
Identifier Source: org_study_id