Clinical trial · Observational
Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC)
An Exosome-based Liquid Biopsy Signature for Pre-operative Identification of Lymph Node Metastasis in Patients With Intrahepatic Cholangiocarcinoma
NCT06381648CI-TRIAL-00105527LyMICcompletedClinicalTrials.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)
Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC. This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiocarcinoma, Intrahepatic | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Cholangiocarcinoma; Liver | — | UNRESOLVED | — |
| Cholangiocarcinoma Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Training)
- description
- Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
- interventionNames
- Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)
- label
- Intrahepatic Cholangiocarcinoma, Without Lymph node metastasis (Training)
- description
- Patients with ICC who did not have lymph node metastases at the time of primary tumor treatment with D2 dissection, in the first cohort.
- interventionNames
- Diagnostic Test: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma)
- label
- Intrahepatic Cholangiocarcinoma, With Lymph node metastasis (Validation)
- description
- Patients with ICC who had lymph node metastases at the time of primary tumor treatment with D2 dissection, in the second cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologically confirmed diagnosis of intrahepatic cholangiocarcinoma. * Received standard diagnostic and staging procedures as per local guidelines * Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment Exclusion Criteria: * Lack of or inability to provide informed consent * Synchronous Intrahepatic cholangiocarcinoma and non- Intrahepatic cholangiocarcinoma diagnosed at or before surgery * Secondary liver cancer
References
Publications (22)
- BACKGROUNDBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- BACKGROUNDAljiffry M, Abdulelah A, Walsh M, Peltekian K, Alwayn I, Molinari M. Evidence-based approach to cholangiocarcinoma: a systematic review of the current literature. J Am Coll Surg. 2009 Jan;208(1):134-47. doi: 10.1016/j.jamcollsurg.2008.09.007. Epub 2008 Oct 31. No abstract available. PMID 19228515
- BACKGROUNDClements O, Eliahoo J, Kim JU, Taylor-Robinson SD, Khan SA. Risk factors for intrahepatic and extrahepatic cholangiocarcinoma: A systematic review and meta-analysis. J Hepatol. 2020 Jan;72(1):95-103. doi: 10.1016/j.jhep.2019.09.007. Epub 2019 Sep 16. PMID 31536748
- BACKGROUNDVan Dyke AL, Shiels MS, Jones GS, Pfeiffer RM, Petrick JL, Beebe-Dimmer JL, Koshiol J. Biliary tract cancer incidence and trends in the United States by demographic group, 1999-2013. Cancer. 2019 May 1;125(9):1489-1498. doi: 10.1002/cncr.31942. Epub 2019 Jan 15. PMID 30645774
- BACKGROUNDGuglielmi A, Ruzzenente A, Campagnaro T, Pachera S, Valdegamberi A, Nicoli P, Cappellani A, Malfermoni G, Iacono C. Intrahepatic cholangiocarcinoma: prognostic factors after surgical resection. World J Surg. 2009 Jun;33(6):1247-54. doi: 10.1007/s00268-009-9970-0. PMID 19294467
- BACKGROUNDBerretta M, Cavaliere C, Alessandrini L, Stanzione B, Facchini G, Balestreri L, Perin T, Canzonieri V. Serum and tissue markers in hepatocellular carcinoma and cholangiocarcinoma: clinical and prognostic implications. Oncotarget. 2017 Feb 21;8(8):14192-14220. doi: 10.18632/oncotarget.13929. PMID 28077782
- BACKGROUNDAltman AM, Kizy S, Marmor S, Huang JL, Denbo JW, Jensen EH. Current survival and treatment trends for surgically resected intrahepatic cholangiocarcinoma in the United States. J Gastrointest Oncol. 2018 Oct;9(5):942-952. doi: 10.21037/jgo.2017.11.06.