Clinical trial · Interventional
Evaluation of a New Blood-based Test to Detect Colorectal Cancer and Its Precursors
CELTiC Trial: an International Multicentre Study Evaluating the CELTiC Panel for the Detection of Advanced Neoplasia in Fecal Immunochemical Test (FIT)-Positive Individuals
- 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 CELTiC panel is a potential blood-based test for detecting colorectal cancer (CRC) and precursors of CRC. This can be useful for CRC screening, since this requires tests that detect cancer in an early stage to maximize the chances of successful treatment. CELTiC combines four markers that can be detected in blood. These markers are composed of so-called messenger RNA (mRNA) and can be viewed as the instructions of our genes to the cell to make certain proteins. Cancer is the result of mutation in these genes. Thus, the mRNA in cancer patients is, depending on the type of mRNA, often abnormal. In earlier studies, the developers of CELTiC found four mRNA's that are different in patients with CRC compared to healthy individuals. However, CELTiC has not yet been extensively studied in individuals for whom the test is intended: a population undergoing CRC screening. The current study aims to fill this gap. We will assess the ability of CELTiC to detect CRC and precursors of CRC in a population of individuals between 50 and 75 years old in the Netherlands and Italy. This population has already been preselected by having a positive fecal immunochemical test (FIT), a test that is frequently used in CRC screening. This population will undergo a colonoscopy, a procedure where a doctor enters the large bowel through the anus using a flexible camara to assess whether the patient has cancer. Prior to this colonoscopy, we will collect blood samples from the individuals to assess their CELTiC score. After the colonoscopy and the blood analysis, we can assess whether the test adequately detects CRC and precursors of CRC in this population.
Conditions
Conditions (5)
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 Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CELTiC test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FIT positive individuals
- description
- FIT-positive individuals of whom we will collect blood samples and who will undergo a colonoscopy after blood sampling.
- interventionNames
- Diagnostic Test: CELTiC test
Primary outcomes (1)
- measure
- Sensitivity of CELTiC
- timeFrame
- AN will be measured at colonoscopy, right after the blood samples needed to assess CELTiC have been collected. Analysis of the blood samples will be conducted after colonoscopy.
- description
- The sensitivity of the CELTiC test for detecting advanced neoplasia
Secondary outcomes (3)
- measure
- Specificity of CELTiC
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * FIT concentration of 20 ug Hb/g or higher (Italy) or 47 ug Hb/g or higher (Netherlands) in the national CRC screening program as reason for referral. * Age between 55 and 75 years (Netherlands) or 50 and 69 years (Italy) Exclusion Criteria: * No signed informed consent * History or current treatment for colorectal cancer * History of inflammatory bowel disease * History of other condition for which colonoscopy surveillance is planned within the next 5 years.
References
Publications (9)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDArnold M, Sierra MS, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global patterns and trends in colorectal cancer incidence and mortality. Gut. 2017 Apr;66(4):683-691. doi: 10.1136/gutjnl-2015-310912. Epub 2016 Jan 27. PMID 26818619
- BACKGROUNDSchreuders EH, Ruco A, Rabeneck L, Schoen RE, Sung JJ, Young GP, Kuipers EJ. Colorectal cancer screening: a global overview of existing programmes. Gut. 2015 Oct;64(10):1637-49. doi: 10.1136/gutjnl-2014-309086. Epub 2015 Jun 3. PMID 26041752
- BACKGROUNDRan T, Cheng CY, Misselwitz B, Brenner H, Ubels J, Schlander M. Cost-Effectiveness of Colorectal Cancer Screening Strategies-A Systematic Review. Clin Gastroenterol Hepatol. 2019 Sep;17(10):1969-1981.e15. doi: 10.1016/j.cgh.2019.01.014. Epub 2019 Jan 16. PMID 30659991
- BACKGROUNDRodia MT, Solmi R, Pasini F, Nardi E, Mattei G, Ugolini G, Ricciardiello L, Strippoli P, Miglio R, Lauriola M. LGALS4, CEACAM6, TSPAN8, and COL1A2: Blood Markers for Colorectal Cancer-Validation in a Cohort of Subjects With Positive Fecal Immunochemical Test Result. Clin Colorectal Cancer. 2018 Jun;17(2):e217-e228. doi: 10.1016/j.clcc.2017.12.002. Epub 2017 Dec 12. PMID 29352642
- BACKGROUNDFerlizza E, Solmi R, Miglio R, Nardi E, Mattei G, Sgarzi M, Lauriola M. Colorectal cancer screening: Assessment of CEACAM6, LGALS4, TSPAN8 and COL1A2 as blood markers in faecal immunochemical test negative subjects. J Adv Res. 2020 Mar 3;24:99-107. doi: 10.1016/j.jare.2020.03.001. eCollection 2020 Jul. PMID 32257432
- BACKGROUNDSenore C, Basu P, Anttila A, Ponti A, Tomatis M, Vale DB, Ronco G, Soerjomataram I, Primic-Zakelj M, Riggi E, Dillner J, Elfstrom MK, Lonnberg S, Sankaranarayanan R, Segnan N. Performance of colorectal cancer screening in the European Union Member States: data from the second European screening report. Gut. 2019 Jul;68(7):1232-1244. doi: 10.1136/gutjnl-2018-317293. Epub 2018 Dec 10.