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

December 8, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48995

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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity for Colorectal Cancer
Time Frame: 90 days
Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
90 days
Specificity for Advanced Colorectal Neoplasia
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity for Advanced Precancerous Lesion
Time Frame: 90 days
Proportion of participants with a positive test result among those who had a diagnosis of advanced precancerous lesions
90 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Census-adjusted Sensitivity for Colorectal Cancer
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days
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
Time Frame: 90 days
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Freenome Holdings Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aasma Shaukat, MD, MPH, NYU Langone Health
  • Principal Investigator: Theodore R Levin, MD, Kaiser Permanente Division of Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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