Study Name:
Prevention of Colorectal Cancer Through Multiomics Blood Testing (Freenome 005)

Description:
An The Freenome 005 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.

 Eligibility:
The study will enroll approximately 40,000 participants across a range of racial, ethnic, and socioeconomic backgrounds.

Study Population: Participants aged between 45 and 85 who are eligible for CRC screening and scheduled for a standard-of-care screening colonoscopy.

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

Participation:

Cohort A – Pre colonoscopy

Cohort B- Post colonoscopy with partially intact advanced adenoma or pre-treated cancer

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.

Test Result Reporting:

This is an observational specimen collection study: no results will be reported to the Investigator or participant.