Prevention of Colorectal Cancer Through Multiomics Blood Testing
Purpose
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.
Conditions
- Colon Cancer
- Rectal Cancer
- Colon Neoplasm
- Colon Diseases
- Colon Lesion
- Colon Polyp
- Colorectal Cancer
- Polyp
- Adenoma
- Rectal Diseases
- Gastrointestinal Tract Cancers
Eligibility
- Eligible Ages
- Between 45 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
Exclusion Criteria
- 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 Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
More Details
- Status
- Active, not recruiting
- Sponsor
- Freenome Holdings Inc.
Study Contact
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.