Clinical trial · Observational
Prevention of Colorectal Cancer Through Multiomics Blood Testing
NCT04369053CI-TRIAL-00099694PREEMPT CRCcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colon Diseases | — | UNRESOLVED | — |
| Colon Lesion | — | UNRESOLVED | — |
| Colon Neoplasm | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colon Polyp | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Tract Cancers | — | UNRESOLVED | — |
| Polyp | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Diseases |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Freenome test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Sensitivity for Colorectal Cancer
- timeFrame
- 90 days
- description
- Proportion of participants with a positive test result among those who had a diagnosis of colorectal cancer
- measure
- Specificity for Advanced Colorectal Neoplasia
- timeFrame
- 90 days
- description
- Proportion of participants with a negative test result among those who had non-advanced precancerous lesions or negative findings (non-neoplastic or no findings)
- measure
- Negative Predictive Value for Advanced Colorectal Neoplasia
- timeFrame
- 90 days
- description
- Proportion of participants with a diagnosis of non-advanced precancerous lesions or negative findings (non-neoplastic or no findings) among those who had a negative test result
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDShaukat A, Burke CA, Chan AT, Grady WM, Gupta S, Katona BW, Ladabaum U, Liang PS, Liu JJ, Putcha G, Robertson DJ, Schoen RE, Meng Z, Piscitello A, Sun CK, Xu C, Lin CJ, Lee LC, Baldo L, Levin TR; PREEMPT CRC Investigators. Clinical Validation of a Circulating Tumor DNA-Based Blood Test to Screen for Colorectal Cancer. JAMA. 2025 Jul 1;334(1):56-63. doi: 10.1001/jama.2025.7515. PMID 40455622
- DERIVEDKortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10. PMID 40207404
- DERIVEDMills K, Figueroa F, Knight R, Ekpo E, Lee LC, Baldo L, Xu C, Wang S, Adelman RM, Pemu P, Levin T, Shaukat A, Liu JJ. Fact or Myth? Black Patients Do Not Want to Participate in Clinical Trials. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00826. doi: 10.14309/ctg.0000000000000826. PMID 39878425