NCT06342414|Recruiting
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
ELUCIDATE
Loading search results
ELUCIDATE
Sponsor study identifier
observational
400
2 countries
5
Study Start
March 15, 2024
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2024
Actual (reported)March 26, 2024
Actual (reported)April 2, 2024
Actual (reported)June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Through study completion, an average of 1 year
Specificity
Through study completion, an average of 1 year
Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy)
Through study completion, an average of 1 year
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Individuals who were diagnosed with either intrahepatic cholangiocarcinoma or hepatocellular carcinoma (case-case design for a differential diagnosis study)
City of Hope Medical Center
Duarte, California, 91010, United States
Graduate School of Medical Sciences, Kyushu University
Fukuoka, Japan
Marrero 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.
Wu 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.
Ajay Goel, PhD
City of Hope Medical Center
First Submitted
March 26, 2024
First Posted
April 2, 2024
Study Start
March 15, 2024
Actual (reported)Primary Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
Contact the study team to confirm eligibility.
Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan
Hokkaido University Graduate School of Medicine
Sapporo, Japan
Tokushima University
Tokushima, Japan
El-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.
Vigano 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.
Kovac 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.
Arbelaiz 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.
Banales JM, Inarrairaegui M, Arbelaiz A, Milkiewicz P, Muntane J, Munoz-Bellvis L, La Casta A, Gonzalez LM, Arretxe E, Alonso C, Martinez-Arranz I, Lapitz A, Santos-Laso A, Avila MA, Martinez-Chantar ML, Bujanda L, Marin JJG, Sangro B, Macias RIR. Serum Metabolites as Diagnostic Biomarkers for Cholangiocarcinoma, Hepatocellular Carcinoma, and Primary Sclerosing Cholangitis. Hepatology. 2019 Aug;70(2):547-562. doi: 10.1002/hep.30319. Epub 2019 Feb 14.
Huang C, Xu X, Wang M, Xiao X, Cheng C, Ji J, Fang M, Gao C. Serum N-glycan fingerprint helps to discriminate intrahepatic cholangiocarcinoma from hepatocellular carcinoma. Electrophoresis. 2021 Jun;42(11):1187-1195. doi: 10.1002/elps.202000392. Epub 2021 Mar 1.
Chen VL, Xu D, Wicha MS, Lok AS, Parikh ND. Utility of Liquid Biopsy Analysis in Detection of Hepatocellular Carcinoma, Determination of Prognosis, and Disease Monitoring: A Systematic Review. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2879-2902.e9. doi: 10.1016/j.cgh.2020.04.019. Epub 2020 Apr 11.
Foda ZH, Annapragada AV, Boyapati K, Bruhm DC, Vulpescu NA, Medina JE, Mathios D, Cristiano S, Niknafs N, Luu HT, Goggins MG, Anders RA, Sun J, Meta SH, Thomas DL, Kirk GD, Adleff V, Phallen J, Scharpf RB, Kim AK, Velculescu VE. Detecting Liver Cancer Using Cell-Free DNA Fragmentomes. Cancer Discov. 2023 Mar 1;13(3):616-631. doi: 10.1158/2159-8290.CD-22-0659.
Lapitz A, Azkargorta M, Milkiewicz P, Olaizola P, Zhuravleva E, Grimsrud MM, Schramm C, Arbelaiz A, O'Rourke CJ, La Casta A, Milkiewicz M, Pastor T, Vesterhus M, Jimenez-Aguero R, Dill MT, Lamarca A, Valle JW, Macias RIR, Izquierdo-Sanchez L, Perez Castano Y, Caballero-Camino FJ, Riano I, Krawczyk M, Ibarra C, Bustamante J, Nova-Camacho LM, Falcon-Perez JM, Elortza F, Perugorria MJ, Andersen JB, Bujanda L, Karlsen TH, Folseraas T, Rodrigues PM, Banales JM. Liquid biopsy-based protein biomarkers for risk prediction, early diagnosis, and prognostication of cholangiocarcinoma. J Hepatol. 2023 Jul;79(1):93-108. doi: 10.1016/j.jhep.2023.02.027. Epub 2023 Mar 1.
Wang P, Song Q, Ren J, Zhang W, Wang Y, Zhou L, Wang D, Chen K, Jiang L, Zhang B, Chen W, Qu C, Zhao H, Jiao Y. Simultaneous analysis of mutations and methylations in circulating cell-free DNA for hepatocellular carcinoma detection. Sci Transl Med. 2022 Nov 23;14(672):eabp8704. doi: 10.1126/scitranslmed.abp8704. Epub 2022 Nov 23.
Ye Q, Ling S, Zheng S, Xu X. Liquid biopsy in hepatocellular carcinoma: circulating tumor cells and circulating tumor DNA. Mol Cancer. 2019 Jul 3;18(1):114. doi: 10.1186/s12943-019-1043-x.
Li S, Yao J, Xie M, Liu Y, Zheng M. Exosomal miRNAs in hepatocellular carcinoma development and clinical responses. J Hematol Oncol. 2018 Apr 11;11(1):54. doi: 10.1186/s13045-018-0579-3.
Sasaki R, Kanda T, Yokosuka O, Kato N, Matsuoka S, Moriyama M. Exosomes and Hepatocellular Carcinoma: From Bench to Bedside. Int J Mol Sci. 2019 Mar 20;20(6):1406. doi: 10.3390/ijms20061406.
Wang M, Gao Y, Feng H, Warner E, An M, Jia J, Chen S, Fang M, Ji J, Gu X, Gao C. A nomogram incorporating six easily obtained parameters to discriminate intrahepatic cholangiocarcinoma and hepatocellular carcinoma. Cancer Med. 2018 Mar;7(3):646-654. doi: 10.1002/cam4.1341. Epub 2018 Feb 23.
Si YQ, Wang XQ, Pan CC, Wang Y, Lu ZM. An Efficient Nomogram for Discriminating Intrahepatic Cholangiocarcinoma From Hepatocellular Carcinoma: A Retrospective Study. Front Oncol. 2022 Apr 11;12:833999. doi: 10.3389/fonc.2022.833999. eCollection 2022.
Wang Y, Zhang C, Zhang P, Guo G, Jiang T, Zhao X, Jiang J, Huang X, Tong H, Tian Y. Serum exosomal microRNAs combined with alpha-fetoprotein as diagnostic markers of hepatocellular carcinoma. Cancer Med. 2018 May;7(5):1670-1679. doi: 10.1002/cam4.1390. Epub 2018 Mar 23.
Study Completion
June 18, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 7, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: