Clinical trial · Observational
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
NCT06342414CI-TRIAL-00117102ELUCIDATErecruitingClinicalTrials.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)
It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery.
Conditions
Conditions (7)
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 |
| Hepatic Cancer | — | UNRESOLVED | — |
| Hepatic Carcinoma | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Liver Cancer | — | UNRESOLVED | — |
| Primary Liver Carcinoma | Liver Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELUCIDATE | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Hepatocellular Carcinoma (Training)
- description
- A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
- interventionNames
- Diagnostic Test: ELUCIDATE
- label
- Intrahepatic Cholangiocarcinoma (Training)
- description
- A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
- interventionNames
- Diagnostic Test: ELUCIDATE
- label
- Hepatocellular Carcinoma (Validation)
- description
- A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
- interventionNames
- Diagnostic Test: ELUCIDATE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A histologically confirmed diagnosis of hepatocellular carcinoma * 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 hepatocellular carcinoma and intrahepatic cholangiocarcinoma * Primary liver cancer other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma * Secondary liver cancer
References
Publications (18)
- BACKGROUNDMarrero JA, Kulik LM, Sirlin CB, Zhu AX, Finn RS, Abecassis MM, Roberts LR, Heimbach JK. Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750. doi: 10.1002/hep.29913. No abstract available. PMID 29624699
- BACKGROUNDWu Y, Xia C, Chen J, Qin Q, Ye Z, Song B. Diagnostic performance of magnetic resonance imaging and contrast-enhanced ultrasound in differentiating intrahepatic cholangiocarcinoma from hepatocellular carcinoma: a meta-analysis. Abdom Radiol (NY). 2024 Jan;49(1):34-48. doi: 10.1007/s00261-023-04064-z. Epub 2023 Oct 12. PMID 37823913
- BACKGROUNDEl-Serag HB, Marrero JA, Rudolph L, Reddy KR. Diagnosis and treatment of hepatocellular carcinoma. Gastroenterology. 2008 May;134(6):1752-63. doi: 10.1053/j.gastro.2008.02.090. PMID 18471552
- BACKGROUNDVigano L, Lleo A, Muglia R, Gennaro N, Sama L, Colapietro F, Roncalli M, Aghemo A, Chiti A, Di Tommaso L, Solbiati L, Colombo M, Torzilli G. Intrahepatic cholangiocellular carcinoma with radiological enhancement patterns mimicking hepatocellular carcinoma. Updates Surg. 2020 Jun;72(2):413-421. doi: 10.1007/s13304-020-00750-5. Epub 2020 Apr 22. PMID 32323164
- BACKGROUNDKovac JD, Jankovic A, Dikic-Rom A, Grubor N, Antic A, Dugalic V. Imaging Spectrum of Intrahepatic Mass-Forming Cholangiocarcinoma and Its Mimickers: How to Differentiate Them Using MRI. Curr Oncol. 2022 Jan 30;29(2):698-723. doi: 10.3390/curroncol29020061. PMID 35200560
- BACKGROUNDArbelaiz A, Azkargorta M, Krawczyk M, Santos-Laso A, Lapitz A, Perugorria MJ, Erice O, Gonzalez E, Jimenez-Aguero R, Lacasta A, Ibarra C, Sanchez-Campos A, Jimeno JP, Lammert F, Milkiewicz P, Marzioni M, Macias RIR, Marin JJG, Patel T, Gores GJ, Martinez I, Elortza F, Falcon-Perez JM, Bujanda L, Banales JM. Serum extracellular vesicles contain protein biomarkers for primary sclerosing cholangitis and cholangiocarcinoma. Hepatology. 2017 Oct;66(4):1125-1143. doi: 10.1002/hep.29291. Epub 2017 Aug 26.