Clinical trial · Observational
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer
Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
NCT06889883CI-TRIAL-00096110ColoDixrecruitingClinicalTrials.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)
This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.
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 Adenomas (AA) | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Healthy
- description
- Individual with no findings or findings not related to neoplasia on colonoscopy
- label
- Advanced Adenoma
- description
- Patient diagnosed with advanced adenoma by colonoscopy and confirmed by histology result
- label
- Colorectal Cancer
- description
- Patient diagnosed with colorectal cancer by colonoscopy and confirmed by histology result
Primary outcomes (1)
- measure
- Clinical Validation
- timeFrame
- 36 months
- description
- To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over the age of 18 who are able to understand the participant information and sign the informed consent. * Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC). Exclusion Criteria: * Patients who had developed any type of cancer in the 5 years prior to their participation in this study. * Patients who have received previous chemotherapy or radiotherapy. * Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome. * Patients with inadequate bowel preparation for colonoscopy. * Patients who have undergone colonoscopy/polipectomy in the previous 5 years. * Patients with hemolyzed plasma.
References
Publications (4)
- BACKGROUNDHerreros-Villanueva M, Duran-Sanchon S, Martin AC, Perez-Palacios R, Vila-Navarro E, Marcuello M, Diaz-Centeno M, Cubiella J, Diez MS, Bujanda L, Lanas A, Jover R, Hernandez V, Quintero E, Jose Lozano J, Garcia-Cougil M, Martinez-Arranz I, Castells A, Gironella M, Arroyo R. Plasma MicroRNA Signature Validation for Early Detection of Colorectal Cancer. Clin Transl Gastroenterol. 2019 Jan;10(1):e00003. doi: 10.14309/ctg.0000000000000003. PMID 30702491
- BACKGROUNDGiraldez MD, Lozano JJ, Ramirez G, Hijona E, Bujanda L, Castells A, Gironella M. Circulating microRNAs as biomarkers of colorectal cancer: results from a genome-wide profiling and validation study. Clin Gastroenterol Hepatol. 2013 Jun;11(6):681-8.e3. doi: 10.1016/j.cgh.2012.12.009. Epub 2012 Dec 23. PMID 23267864
- BACKGROUNDWinawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701. PMID 8247072
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338