Clinical trial · Observational
Prospective Clinical Validation of a Novel Multitarget FIT in CRC Screening
Clinical Validation of a Multi-target Faecal Immunochemical Test (mtFIT) Versus a Faecal Immunochemical Test (FIT) for Detecting Advanced Neoplasia in Population Screening for CRC: a Prospective Cohort Study With Paired Design
- 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 primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Neoplasia | Neoplasm | CURATED_BROADER | 0.78 |
| CRC | Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison of two tests (FIT and mtFIT) in the same bowel movement | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- mtFIT
- description
- Individuals who consent to participate in the study, will be asked to take two stool samples from the same bowel movement. In a central laboratory these two samples then will be analyzed. One with the standard of care faecal immunochemical test (FIT) and the other with the multi-target faecal immunochemical test (mtFIT). If either one of these two tests is positive, individuals will be referred to undergo a colonoscopy procedure. The performance of mtFIT, in comparison to FIT, will be evaluated against the colonoscopy findings.
- interventionNames
- Diagnostic Test: Comparison of two tests (FIT and mtFIT) in the same bowel movement
Primary outcomes (1)
- measure
- Detection rate of advanced neoplasia
- timeFrame
- 10 months
- description
- Relative sensitivity of mtFIT compared to FIT in the detection of advanced neoplasia (AN; CRC, advanced adenomas and advanced serrated polyps) at an equal positivity rate.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals of the Dutch population suitable for CRC screening (age between 55 and 75 years old) will be randomly selected. * The participants will be invited in phases and are selected out of different age groups. * The selected participants will participate in the population CRC screening program for either the first, second, third or fourth time. Exclusion Criteria: * Collection of stool not complete for both tests (FIT and mtFIT)
References
Publications (2)
- DERIVEDWisse PHA, de Klaver W, van Wifferen F, van Maaren-Meijer FG, van Ingen HE, Meiqari L, Huitink I, Bierkens M, Lemmens M, Greuter MJE, van Leerdam ME, Spaander MCW, Dekker E, Coupe VMH, Carvalho B, de Wit M, Meijer GA. The multitarget faecal immunochemical test for improving stool-based colorectal cancer screening programmes: a Dutch population-based, paired-design, intervention study. Lancet Oncol. 2024 Mar;25(3):326-337. doi: 10.1016/S1470-2045(23)00651-4. Epub 2024 Feb 9. PMID 38346438
- DERIVEDWisse PHA, de Klaver W, van Wifferen F, Meiqari L, Bierkens M, Greuter MJE, Carvalho B, van Leerdam ME, Spaander MCW, Dekker E, Coupe VMH, de Wit M, Meijer GA. The multitarget fecal immunochemical test versus the fecal immunochemical test for programmatic colorectal cancer screening: a cross-sectional intervention study with paired design. BMC Cancer. 2022 Dec 12;22(1):1299. doi: 10.1186/s12885-022-10372-2. PMID 36503495