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

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: Completed
• Conditions: Rectal Diseases; Colorectal Cancer; Adenoma; Rectal Cancer; Colon Cancer; Colon Polyp; Colon Lesion; Colon Neoplasm; Polyp; Colon Diseases; Gastrointestinal Tract Cancers
• Intervention / Treatment: Diagnostic test: Freenome test

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 (Actual): 48995

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Forzani and MacPhail Colon Cancer Screening Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Alabama Oncology
    • Birmingham, Alabama, United States, 35209
      • Central Alabama Research
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Del Sol Research Management
    • Scottsdale, Arizona, United States, 85258
      • Honor Health
    • Tucson, Arizona, United States, 85710
      • Del Sol Research Management,
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Preferred Research Partners
    • Springdale, Arkansas, United States, 72762
      • Highlands Oncology Group
  • California
    • Chula Vista, California, United States, 91910
      • Precision Research Institute
    • Concord, California, United States, 94520
      • John Muir Health
    • Corona, California, United States, 92883
      • Carbon Health
    • El Cajon, California, United States, 92021
      • Miller Bioconnect
    • Escondido, California, United States, 92025
      • Gastroenterology and Liver Institute
    • Fresno, California, United States, 93710
      • Women's Cancer Network
    • La Mesa, California, United States, 91942
      • San Diego Clinical Trials
    • Los Angeles, California, United States, 90230
      • Science 37
    • Los Angeles, California, United States, 90048
      • Urology Alliance Clinical Research
    • Merced, California, United States, 95340
      • Mercy Cancer Center
    • Oxnard, California, United States, 93030
      • Diverse Research Solutions
    • Pomona, California, United States, 91767
      • Pomona Valley Hospital Medical Center/Cancer Care Center
    • San Francisco, California, United States, 94117
      • St. Mary's Medical Center
    • Santa Cruz, California, United States, 94520
      • Dominican Hospital Dignity Health
    • Stockton, California, United States, 95204
      • Stockton Hematology Oncology
    • Torrance, California, United States, 90505
      • Torrance Memorial Physician Network - Cancer Care
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Gastroenterology Associates of Fairfield County
    • Norwich, Connecticut, United States, 06360
      • Eastern CT Hematology and Oncology Associates
    • Stamford, Connecticut, United States, 06902
      • Stamford Hospital
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • RecioMed Clinical Research
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research
    • Doral, Florida, United States, 33166
      • Universal Axon Clinical Research
    • Hialeah, Florida, United States, 33016
      • Palmetto Research
    • Homestead, Florida, United States, 33030
      • Clinical Research of Homestead
    • Kissimmee, Florida, United States, 34741
      • I.H.S Health, LLC
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology & Oncology Center
    • Palm Harbor, Florida, United States, 34684
      • Advanced Gastroenterology Associates, LLC
    • Panama City, Florida, United States, 32405
      • Emerald Coast OBGYN
    • Pensacola, Florida, United States, 32504
      • Ascension Sacred Heart
    • Port Orange, Florida, United States, 32127
      • United Medical Research
    • The Villages, Florida, United States, 32162
      • Charter Research
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • Morehouse School of Medicine
    • Cordele, Georgia, United States, 31015
      • Crisp Regional Hospital
    • Dublin, Georgia, United States, 31021
      • Cancer Center of Middle Georgia (QCCA)
    • Gainesville, Georgia, United States, 30501
      • SpeciCare, Inc
    • Gainesville, Georgia, United States, 30501
      • Specicare
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Deerfield, Illinois, United States, 60015
      • Walgreens
    • Orland Park, Illinois, United States, 47006
      • Silver Cross Hospital and Medical centers
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology
    • Rolling Meadows, Illinois, United States, 60008
      • Northwest Oncology & Hematology
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic, LLP
  • Indiana
    • Batesville, Indiana, United States, 47006
      • Margaret Mary
    • South Bend, Indiana, United States, 46635
      • Objective Health Network (Digestive Research Alliance of Michiana, LLC)
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Aton Health
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospital, Wichita
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Wichita
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Saint Joseph Cancer Center
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Delta Research Partners
    • Metairie, Louisiana, United States, 70006
      • New Orleans Research Institute
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
    • Shreveport, Louisiana, United States, 71103
      • Louisiana State University Health Sciences Center
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center
    • Baltimore, Maryland, United States, 21237
      • Ascension St. Agnes Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health
    • Rochester Hills, Michigan, United States, 48309
      • Ascension Providence Rochester Hospital
    • Saginaw, Michigan, United States, 48604
      • Covenant HealthCare
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health Cancer institute
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota, School of Public Health, Environmental Health Sciences
    • Winona, Minnesota, United States, 55987
      • Winona Health System
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • Memorial Hospital at Gulfport
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Central Care Cancer Center
    • Carrollton, Missouri, United States, 64633
      • Carroll County Memorial Hospital
    • Hannibal, Missouri, United States, 63401
      • Hannibal Regional Hospital
    • Kansas City, Missouri, United States, 64108
      • University Health Truman Medical Center
    • North Kansas City, Missouri, United States, 64116
      • North Kansas City Hospital
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
    • Kalispell, Montana, United States, 59901
      • Logan Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center
    • Reno, Nevada, United States, 93710
      • Cancer Care Specialists Reno
  • New Jersey
    • Mullica Hill, New Jersey, United States, 08062
      • Inspira Medical Center
    • Paterson, New Jersey, United States, 07503
      • St Joseph University
    • Vineland, New Jersey, United States, 08360
      • Inspira Medical Center Vineland
  • New York
    • Binghamton, New York, United States, 13905
      • Our Lady of Lourdes Hospital
    • New York, New York, United States, 10010
      • NYU
    • Port Jefferson Station, New York, United States, 11776
      • NY Cancer & Blood Specialists
    • White Plains, New York, United States, 10601
      • White Plains Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Statesville, North Carolina, United States, 28677
      • Iredell Memorial Hospital
    • Wilmington, North Carolina, United States, 28403
      • Trial Management Associates
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Dayton, Ohio, United States, 45414
      • Objective Health Network
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical
    • Oklahoma City, Oklahoma, United States, 73102
      • Hightower Clinical Research
  • Oregon
    • Bend, Oregon, United States, 97701
      • St. Charles Health System, Inc
    • Portland, Oregon, United States, 97201
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University
  • Pennsylvania
    • Bloomsburg, Pennsylvania, United States, 17815
      • Geisinger Bloomsburg Hospital
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Health
    • DuBois, Pennsylvania, United States, 15801
      • Clinical Research Associates of Central PA
    • Gettysburg, Pennsylvania, United States, 17325
      • Pennsylvania Cancer Specialists & Research Institute
    • Lancaster, Pennsylvania, United States, 17601
      • US Digestive Health at Lancaster
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19141
      • Thomas Jefferson University
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group
    • Wyomissing, Pennsylvania, United States, 19160
      • USDH Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • US Digestive Health at Wyomissing
    • York, Pennsylvania, United States, 17403
      • Cancer Care Associates of York (QCCA)
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Florence, South Carolina, United States, 29506
      • McLeod Health
    • Florence, South Carolina, United States, 29506
      • MacLeod Center for Cancer Treatment and Research
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates
  • South Dakota
    • Pierre, South Dakota, United States, 57104
      • Circle Clinical Research
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • ObjectiveHealth, Inc
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic, PA
  • Texas
    • Austin, Texas, United States, 78738
      • Elligo Health Research, Inc.
    • Corpus Christi, Texas, United States, 78404
      • CHRISTUS Spohn Shoreline Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas M.D. Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Oncology Consultants
    • Houston, Texas, United States, 77008
      • Horizon Clinical Research Group
    • Tyler, Texas, United States, 75702
      • Christus Trinity Mother Frances Health System
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Gastroenterology Associates of Tidewater
    • Fairfax, Virginia, United States, 22031
      • Verity Research Inc
    • Fairfax, Virginia, United States, 22031
      • Inova
    • Lynchburg, Virginia, United States, 24501
      • Centra Lynchburg Hematology Oncology
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Washington Gastroenterology
    • Tacoma, Washington, United States, 98405
      • Northwest Medical Specialties (QCCA)
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • SSM Health-Dean Medical Group
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53211
      • Ascension Columbia St. Mary's Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 81 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for Colorectal Cancer	Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer	90 days
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)	90 days
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	90 days
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	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity for Advanced Precancerous Lesion	Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Census-adjusted Sensitivity for Colorectal Cancer	U.S. census sex- and age-adjusted sensitivity for colorectal cancer Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer	90 days
Census-adjusted Specificity for Advanced Colorectal Neoplasia	U.S. census sex- and age-adjusted 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)	90 days
Census-adjusted Negative Predictive Value for Advanced Colorectal Neoplasia	U.S. census sex- and age-adjusted 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	90 days
Census-adjusted Positive Predictive Value for Advanced Colorectal Neoplasia	U.S. census sex- and age-adjusted 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	90 days
Census-adjusted Sensitivity for Advanced Precancerous Lesion	U.S. census sex- and age-adjusted sensitivity for advanced precancerous lesion Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions	90 days

Collaborators and Investigators

• Sponsor: Freenome Holdings Inc.
• Investigators: Principal Investigator: Aasma Shaukat, MD, MPH, NYU Langone Health; Principal Investigator: Theodore R Levin, MD, Kaiser Permanente Division of Research

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 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): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Screening; Colonoscopy; Artificial Intelligence; Genomics; Liquid Biopsy; CRC; Colorectal Cancer Screening; Colorectal Cancer (CRC); Machine Learning; Cancer Screening; Cancer Diagnostic; Blood Test Cancer; Genomics Test; Cancer Early Detection Test; Freenome Test
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Neoplasms, Glandular and Epithelial; Intestinal Polyps; Pathological Conditions, Signs and Symptoms; Colonic Diseases; Rectal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Gastrointestinal Neoplasms; Adenoma; Polyps; Colonic Polyps; Rectal Diseases
• 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