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

Freenome

Status: Completed

Conditions: Gastrointestinal Tract Cancers; Colon Lesion; Colon Neoplasm; Colon Diseases; Colon Cancer; Rectal Diseases; Polyp; Colon Polyp; Adenoma; Colorectal Cancer; Rectal Cancer

Treatments: Diagnostic Test: Freenome test

Study type: Observational

Funder types: Industry

Identifiers

NCT04369053

FRNM-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48,995 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design