Clinical trial · Observational
An Exosomal microRNA Signature for Preoperative Staging in Colon Cancer
Machine Learning-Based Exosomal microRNA Signature for Preoperative Staging and Chemotherapy Eligibility in Colon Cancer
- 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)
Recent studies have highlighted the potential benefits of neoadjuvant chemotherapy (NAC) in colon cancer; however, its indication is generally limited to cases corresponding to pathological stage IIB or higher. Accurately identifying such high-risk cases before surgery remains challenging using conventional clinical diagnostics alone. Therefore, we hypothesized that integrating molecular biomarkers with preoperative clinical assessment could provide a more precise and sensitive evaluation of tumor aggressiveness. In this context, we focused on exosomal microRNAs, which are actively secreted from tumor cells and remain stable in circulation, and aimed to develop a machine learning-based biomarker panel. To achieve this, we initiated a multicenter study utilizing preoperative plasma samples to establish a reliable biomarker model for risk stratification and treatment decision-making in colon cancer.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs） | Diagnostic Test | — | UNRESOLVED |
| Diagnostic Test: EXPOSE RT-qPCR panel | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- High-risk Colon Cancer (Discovery)
- description
- Stage IIB-IV colon cancer; used to identify biomarker candidates
- interventionNames
- Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
- label
- Low-risk Colon Cancer (Discovery)
- description
- Stage I-IIA colon cancer
- interventionNames
- Diagnostic Test: Diagnostic Test: EXPOSE assay（Small RNA-seq of exosomal miRNAs）
- label
- High-risk Colon Cancer (Training)
- description
- Pathological Stage IIB-IV; used to build model
- interventionNames
- Diagnostic Test: Diagnostic Test: EXPOSE RT-qPCR panel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed colon cancer (Stage I-IV, UICC TNM 8th edition) * Underwent curative-intent resection (with or without perioperative therapy) * Preoperative plasma (or serum) samples available * Clinical and prognostic data available Exclusion Criteria: * No written informed consent * Missing preoperative blood samples * Missing survival/recurrence data * Duplicate cases * Non-adenocarcinoma histology
References
Publications (15)
- BACKGROUNDMorgan E, Arnold M, Gini A, Lorenzoni V, Cabasag CJ, Laversanne M, Vignat J, Ferlay J, Murphy N, Bray F. Global burden of colorectal cancer in 2020 and 2040: incidence and mortality estimates from GLOBOCAN. Gut. 2023 Feb;72(2):338-344. doi: 10.1136/gutjnl-2022-327736. Epub 2022 Sep 8. PMID 36604116
- BACKGROUNDCardoso R, Guo F, Heisser T, Hackl M, Ihle P, De Schutter H, Van Damme N, Valerianova Z, Atanasov T, Majek O, Muzik J, Nilbert MC, Tybjerg AJ, Innos K, Magi M, Malila N, Bouvier AM, Bouvier V, Launoy G, Woronoff AS, Cariou M, Robaszkiewicz M, Delafosse P, Poncet F, Katalinic A, Walsh PM, Senore C, Rosso S, Vincerzevskiene I, Lemmens VEPP, Elferink MAG, Johannesen TB, Korner H, Pfeffer F, Bento MJ, Rodrigues J, Alves da Costa F, Miranda A, Zadnik V, Zagar T, Lopez de Munain Marques A, Marcos-Gragera R, Puigdemont M, Galceran J, Carulla M, Chirlaque MD, Ballesta M, Sundquist K, Sundquist J, Weber M, Jordan A, Herrmann C, Mousavi M, Ryzhov A, Hoffmeister M, Brenner H. Colorectal cancer incidence, mortality, and stage distribution in European countries in the colorectal cancer screening era: an international population-based study. Lancet Oncol. 2021 Jul;22(7):1002-1013. doi: 10.1016/S1470-2045(21)00199-6. Epub 2021 May 25. PMID 34048685
- BACKGROUNDTaieb J, Svrcek M, Cohen R, Basile D, Tougeron D, Phelip JM. Deficient mismatch repair/microsatellite unstable colorectal cancer: Diagnosis, prognosis and treatment. Eur J Cancer. 2022 Nov;175:136-157. doi: 10.1016/j.ejca.2022.07.020. Epub 2022 Sep 14. PMID 36115290
- BACKGROUNDSiegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17. PMID 38230766
- BACKGROUNDBurley N, Lee Y, Liu L, Gangi A, Nasseri Y, Atkins K, Zaghiyan K, Murrell Z, Osipov A, Hendifar A, Hitchins M, Gong J. ctDNA-guided adjuvant immunotherapy in colorectal cancer. Immunotherapy. 2024;16(20-22):1197-1202. doi: 10.1080/1750743X.2024.2430941. Epub 2024 Nov 17. PMID 39552190