Clinical trial · Observational
Observational Cross-reactivity Study for Colorectal Cancer Diagnosis
Observational Cross-reactivity Study to Evaluate the Specificity of a Blood Test for Colorectal Cancer Diagnosis Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools
- 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 objective of this observational study is to evaluate the false positive rate of the blood test based on molecular biomarkers and risk factors. A total of 250 patients diagnosed with various cancers and gastrointestinal diseases will be enrolled. The main question to be answered is Does the blood test have a low false positive rate in the main study population? Participants will donate a blood sample as part of their regular medical care for cancer diagnosis and give the consent to know their clinical risk factors.
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 |
|---|---|---|---|
| blood sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer or Gastrointestinal Disease
- description
- A different types of cancer and gastrointestinal disease will be included in the cohort such as breast cancer, bladder cancer, IBDs, Leukemia and Lung cancer.
- interventionNames
- Diagnostic Test: blood sampling
Primary outcomes (1)
- measure
- False Positive Rate
- timeFrame
- 36 month
- description
- To estimate the false positive rate of the blood-based test in the main population of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients older than 18 years of age at the time of blood sample collection. * Subjects must be able to understand the information provided on the participant information sheet, must consent to participate in the study, and must sign the informed consent form. * Patients diagnosed with only one type of cancer (no colorectal cacner) or gastrointestinal disease. Exclusion Criteria: * Patients who have received previous chemotherapy or radiotherapy. * In case of diagnosis of a tumor: patients who have undergone total or partial surgical resection of the tumor. * Patients with a personal history of advanced or non-advanced colorectal adenoma, serrated lesions, colorectal cancer, familial adenomatous polyposis or Lynch syndrome. * Patients without appropriate staging or diagnosis. * Patients with hemolyzed plasma.
References
Publications (3)
- BACKGROUNDSiegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1. PMID 36856579
- 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
- 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