Clinical trial · Observational
Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.
Machine Learning-based Exosome Liquid Biopsy Enables Stratification of Occult Metastasis Risk in Patients With Intrahepatic Cholangiocarcinoma
NCT07224737CI-TRIAL-00105399EXOMICcompletedClinicalTrials.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)
Occult metastasis at the time of surgery is a major driver of poor outcomes in intrahepatic cholangiocarcinoma (ICC), yet reliable preoperative biomarkers to identify such patients are lacking. The EXOMIC study aims to develop and validate a circulating exosomal microRNA (exo-miRNA)-based liquid biopsy assay to detect occult metastasis preoperatively in patients with resectable ICC.
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 |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma (Icc) | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXOMIC assay (qRT-PCR validation) | Diagnostic Test | — | UNRESOLVED |
| EXOMIC small RNA sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Training Cohort - ICC with Occult Metastasis
- description
- The cohort of ICC patients who had occult metastasis detected at the time of surgery. Preoperative samples were analyzed using the EXOMIC qRT-PCR assay to validate candidate exosomal microRNAs identified in the discovery cohort.
- interventionNames
- Diagnostic Test: EXOMIC assay (qRT-PCR validation)
- label
- Training Cohort - ICC without Occult Metastasis
- description
- The cohort of ICC patients without occult metastasis at the time of surgery. Preoperative samples were analyzed with the EXOMIC qRT-PCR assay to evaluate differential miRNA expression and refine the predictive model for occult metastasis detection.
- interventionNames
- Diagnostic Test: EXOMIC assay (qRT-PCR validation)
- label
- Validation Cohort - ICC with Occult Metastasis
- description
- The cohort of ICC patients with occult metastasis at the time of primary tumor resection. The EXOMIC qRT-PCR assay was applied to confirm the predictive value of the exosomal miRNA panel in identifying occult metastasis prior to surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed ICC (clinical stage I-III). * Undergoing curative-intent hepatectomy. * Availability of preoperative pasma or serum sample (≥200 µL). * Standard staging imaging completed per institutional protocol. * Written informed consent. Exclusion Criteria: * Extrahepatic cholangiocarcinoma or gallbladder cancer. * Synchronous non-ICC malignancy. * Inadequate clinical follow-up. * Inability to consent.
References
Publications (13)
- BACKGROUNDHuang G, Zhang H, Yang Z, Li Q, Yuan H, Chen P, Xie C, Meng B, Zhang X, Chen K, Yu H. Predictive value of HTS grade in patients with intrahepatic cholangiocarcinoma undergoing radical resection: a multicenter study from China. World J Surg Oncol. 2024 Jan 11;22(1):17. doi: 10.1186/s12957-023-03281-6. PMID 38200585
- BACKGROUNDSwanson K, Wu E, Zhang A, Alizadeh AA, Zou J. From patterns to patients: Advances in clinical machine learning for cancer diagnosis, prognosis, and treatment. Cell. 2023 Apr 13;186(8):1772-1791. doi: 10.1016/j.cell.2023.01.035. Epub 2023 Mar 10. PMID 36905928
- BACKGROUNDKojima T, Umeda Y, Fuji T, Niguma T, Sato D, Endo Y, Sui K, Inagaki M, Oishi M, Ota T, Hioki K, Matsuda T, Aoki H, Hirai R, Kimura M, Yagi T, Fujiwara T. Efficacy of surgical management for recurrent intrahepatic cholangiocarcinoma: A multi-institutional study by the Okayama Study Group of HBP surgery. PLoS One. 2020 Sep 3;15(9):e0238392. doi: 10.1371/journal.pone.0238392. eCollection 2020. PMID 32881910
- BACKGROUNDFeng J, Liang B, Zhang HY, Liu Z, Jiang K, Zhao XQ. Prognostic factors for patients with mass-forming intrahepatic cholangiocarcinoma: A case series of 68 patients. World J Gastrointest Surg. 2022 May 27;14(5):442-451. doi: 10.4240/wjgs.v14.i5.442. PMID 35734620
- BACKGROUNDDoussot A, Gonen M, Wiggers JK, Groot-Koerkamp B, DeMatteo RP, Fuks D, Allen PJ, Farges O, Kingham TP, Regimbeau JM, D'Angelica MI, Azoulay D, Jarnagin WR. Recurrence Patterns and Disease-Free Survival after Resection of Intrahepatic Cholangiocarcinoma: Preoperative and Postoperative Prognostic Models. J Am Coll Surg. 2016 Sep;223(3):493-505.e2. doi: 10.1016/j.jamcollsurg.2016.05.019. Epub 2016 Jun 11. PMID 27296525
- BACKGROUNDYu TH, Chen X, Zhang XH, Zhang EC, Sun CX. Clinicopathological characteristics and prognostic factors for intrahepatic cholangiocarcinoma: a population-based study. Sci Rep. 2021 Feb 17;11(1):3990. doi: 10.1038/s41598-021-83149-5.