Summary

Eligibility
for people ages 45-85 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Details

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.

Keywords

Colon Cancer Rectal Cancer Colon Neoplasm Colon Diseases Colon Lesion Colon Polyp Colorectal Cancer Polyp Adenoma Rectal Diseases Gastrointestinal Tract Cancers Artificial Intelligence Liquid Biopsy Blood Test Cancer Cancer Diagnostic Genomics Genomics Test CRC Cancer Screening Cancer Early Detection Test Screening Colonoscopy Machine Learning Freenome Test Colorectal Cancer (CRC) Colorectal Cancer Screening Colorectal Neoplasms Colonic Neoplasms Gastrointestinal Neoplasms Colonic Diseases Polyps

Eligibility

You can join if…

Open to people ages 45-85

  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

You CAN'T join if...

  1. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)

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

Locations

  • University of California San Diego Medical Center accepting new patients
    San Diego California 92103 United States
  • Precision Research Institute, LLC accepting new patients
    San Diego California 92114 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Freenome Holdings Inc.
ID
NCT04369053
Study Type
Observational
Last Updated