Clinical trial · Observational
Peripheral Blood Monocytes as Predictive Marker for Colorectal Cancer Diagnosis: A Comparative Study of a Stool Based Versus Blood Based Screening Test
- 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)
In this prospective study, the main goal is to evaluate the strength of Monomark -a monocyte-based transcriptomic test combined to a mathematical model- in patients with a positive FIT test. Therefore, in parallel to the routine FIT screening, blood samples will be harvested and the monocyte genetic profile will be determined. This fundamental study, will disclose the diagnostic power of a biomarker panel ("MonoMark") head to head with the well-established FIT diagnostic test, a core prerequisite for the routine use of this test as an alternative and more reliable CRC screening tool.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MonoMark | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FIT-positive individuals
- description
- Patients being positive to an FIT test performed in the context of the Flemish (Northern Belgium) colorectal cancer screening campaign. These patients are male and female between 56 and 74 years old.
- interventionNames
- Diagnostic Test: MonoMark
Primary outcomes (1)
- measure
- AUC of the MonoMark test
- timeFrame
- Within 1 year after recruitment completion.
- description
- Area Under the ROC Curve (AUC) of the MonoMark test, comparing its predictions to the colonoscopy-confirmed status.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 56 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Having participated to the Flemish (Northern Belgium) Colorectal Screening Campaign and, as a result, having a positive stool test (FIT) outcome. Exclusion Criteria: * None other than non-fulfillment of the inclusion criterion
References
Publications (0)
Data not yet available