Skip to main content
OpenTrials
Completed

NCT Number: NCT04369053

Prevention of Colorectal Cancer Through Multiomics Blood Testing

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Cancer Adenoma Colon Diseases Colon Lesion Colon Neoplasm Colon Polyp Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Tract Cancers Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyp Polyps Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Forzani and MacPhail Colon Cancer Screening Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria

  • 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

Key Exclusion Criteria

  • 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

Treatment and study plan

Freenome Test

Diagnostic 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 names: Single Group Assignment

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Freenome Holdings Inc.

Industry

Registry information

Acronym: PREEMPT CRC

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2020
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.