Clinical trial · Observational
An Exosomal miRNA-based Liquid Biopsy for ICC Detection
Liquid Biopsy Using Exosomal miRNA for Intrahepatic Cholangiocarcinoma Detection
NCT07225452CI-TRIAL-00105436LUMICcompletedClinicalTrials.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)
Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor with poor prognosis and limited curative treatment options. Early and accurate detection remains an unmet clinical need. The LUMIC study aims to develop a non-invasive liquid biopsy platform based on both exosomal microRNAs (exo-miRNAs) to detect intrahepatic cholangiocarcinoma with high sensitivity and specificity.
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 |
|---|---|---|---|
| LUMIC assay | Diagnostic Test | — | UNRESOLVED |
| Small RNA sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Intrahepatic Cholangiocarcinoma (Discovery, Small RNA-seq)
- description
- Serum and plasma samples from patients with histologically confirmed ICC will be analyzed using small RNA sequencing to identify circulating miRNAs specifically upregulated in ICC. These miRNAs will serve as candidates for downstream validation.
- interventionNames
- Diagnostic Test: Small RNA sequencing
- label
- Non-disease Control (Discovery, Small RNA-seq)
- description
- Serum and plasma samples from individuals without malignant or inflammatory liver diseases (benign or healthy controls) will be analyzed in parallel by small RNA sequencing to identify miRNAs differentially expressed between ICC and non-disease controls.
- interventionNames
- Diagnostic Test: Small RNA sequencing
- label
- Intrahepatic Cholangiocarcinoma (Training)
- description
- Patients with histologically confirmed ICC whose pre-treatment serum or plasma samples will be used to construct and optimize the exo-miRNA diagnostic panel based on discovery-phase candidates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed intrahepatic cholangiocarcinoma * Availability of pre-treatment plasma sample * Informed consent provided Exclusion Criteria: * Extrahepatic cholangiocarcinoma * History of other malignancy within 5 years * Active infection, autoimmune disease, or pregnancy * Inadequate clinical data or poor sample quality
References
Publications (12)
- BACKGROUNDLi J, Bao H, Huang Z, Liang Z, Lin N, Ni C, Xu Y. Non-Coding RNA in Cholangiocarcinoma: An Update. Front Biosci (Landmark Ed). 2023 Aug 18;28(8):173. doi: 10.31083/j.fbl2808173. PMID 37664914
- BACKGROUNDSato K, Glaser S, Alvaro D, Meng F, Francis H, Alpini G. Cholangiocarcinoma: novel therapeutic targets. Expert Opin Ther Targets. 2020 Apr;24(4):345-357. doi: 10.1080/14728222.2020.1733528. Epub 2020 Feb 26. PMID 32077341
- BACKGROUNDLuo C, Xin H, Zhou Z, Hu Z, Sun R, Yao N, Sun Q, Borjigin U, Wu X, Fan J, Huang X, Zhou S, Zhou J. Tumor-derived exosomes induce immunosuppressive macrophages to foster intrahepatic cholangiocarcinoma progression. Hepatology. 2022 Oct;76(4):982-999. doi: 10.1002/hep.32387. Epub 2022 Feb 28. PMID 35106794
- BACKGROUNDLi Z, Shen J, Chan MT, Wu WK. The role of microRNAs in intrahepatic cholangiocarcinoma. J Cell Mol Med. 2017 Jan;21(1):177-184. doi: 10.1111/jcmm.12951. Epub 2016 Sep 13. PMID 27619971
- BACKGROUNDWada Y, Shimada M, Morine Y, Ikemoto T, Saito Y, Baba H, Mori M, Goel A. A blood-based noninvasive miRNA signature for predicting survival outcomes in patients with intrahepatic cholangiocarcinoma. Br J Cancer. 2022 May;126(8):1196-1204. doi: 10.1038/s41416-022-01710-z. Epub 2022 Jan 25. PMID 35079106
- BACKGROUNDLiu L, Shi Y, Zhang P, Zhang X. Integration analysis of miRNA-mRNA expression exploring their potential roles in intrahepatic cholangiocarcinoma. Sci Rep. 2023 May 24;13(1):8362. doi: 10.1038/s41598-023-35288-0. PMID 37225858
- BACKGROUNDEuropean Association for the Study of the Liver. EASL-ILCA Clinical Practice Guidelines on the management of intrahepatic cholangiocarcinoma. J Hepatol. 2023 Jul;79(1):181-208. doi: 10.1016/j.jhep.2023.03.010. Epub 2023 Apr 20. PMID 37084797