N/A
N=48,995
Prevention of Colorectal Cancer Through Multiomics Blood Testing
Colon Cancer · Rectal Cancer · Colon Neoplasm · Colon Diseases · Colon Lesion
Bottom Line
View on ClinicalTrials.gov: NCT04369053 ↗Enrolled (actual)
48,995
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Sensitivity for Colorectal Cancer — 79.2 Percent
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Freenome test (Diagnostic_test)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Freenome Holdings Inc.
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity for Colorectal Cancer |
79.2 | — |
| PRIMARY Specificity for Advanced Colorectal Neoplasia |
91.5 | — |
| PRIMARY Negative Predictive Value for Advanced Colorectal Neoplasia |
90.8 | — |
| PRIMARY Positive Predictive Value for Advanced Colorectal Neoplasia |
15.5 | — |
| SECONDARY Sensitivity for Advanced Precancerous Lesion |
12.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04369053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.