Hepatocellular CarcinomaELUCIDATENCT06342414
An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
An observational study of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by City of Hope Medical Center at 5 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma
- What is being tested?
- ELUCIDATE
- How many people
- 400 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Mar 2024to 18 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who were diagnosed with either intrahepatic cholangiocarcinoma or hepatocellular carcinoma (case-case design for a differential diagnosis study)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Japan4 sites, 4 recruiting
- Recruiting
Graduate School of Medical Sciences, Kyushu University
Fukuoka
Tomoharu Yoshizumi
Tomoharu Yoshizumi
- Recruiting
Graduate School of Medical Sciences, Kumamoto University
Kumamoto
Hideo Baba
Hideo Baba
- Recruiting
Hokkaido University Graduate School of Medicine
Sapporo
Akinobu Taketomi
Akinobu Taketomi
- Recruiting
Tokushima University
Tokushima
Mitsuo Shimada
Mitsuo Shimada
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Ajay Goel, PhD, 626-218-3452, AJGOEL@COH.ORG
Caiming Xu, MD, PhD
About this study
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.
Read the detailed description
Primary liver cancers (PLCs) encompass a diverse group of malignancies originating from the liver, collectively ranking as the third leading cause of cancer-related mortality worldwide in 2020. Among PLCs, intrahepatic cholangiocarcinoma (ICC) and hepatocellular carcinoma (HCC) represent the most predominant subtypes. Despite their collective grouping as PLCs, ICC and HCC patients exhibit distinct etiologies, pathologies, and clinical characteristics, necessitating different treatment approaches. Accurate differentiation between ICC and HCC is paramount to optimize patient outcomes and guide personalized treatment decisions. However, a definitive diagnosis is often obtained only after the pathological review of the resected neoplastic tissue, which requires invasive tumor sampling and poses risks of complications such as hemorrhage and tumor cell seeding. Consequently, there is a pressing clinical need to develop noninvasive diagnostic approaches to achieve an accurate differential diagnosis for patients with these distinct forms of PLCs.
This study involves the development and validation of a liquid biopsy, assessing circulating exosomal microRNAs (exo-miRNA) for indirect sampling of tumor tissue in the bloodstream. The researchers intend to harness machine learning and bioinformatics to create a cost-efficient, non-invasive, clinic-friendly assay with high sensitivity and specificity, aiding the differential diagnosis between ICC and HCC.
The researchers intend to do so in three phases:
- To perform comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC.
- To develop and train a differential diagnosis panel based on advanced machine-learning models to obtain a final differential diagnosis biomarker.
- To validate the findings in an independent cohort of ICC and HCC.
In summary, this proposal promises to improve patient care and help clinicians perform a more reliable differential diagnosis between ICC and HCC in patients with primary liver cancer.
- Conditions
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Primary Liver Cancer, Primary Liver Carcinoma, Hepatic Cancer
- Being tested
- ELUCIDATE
- Keywords
- Exosome, micro RNA, Differential Diagnosis
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELUCIDATEDiagnostic test
Also called ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular Carcinoma (Training) | A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC) Receives: Diagnostic Test: ELUCIDATE | |
| Intrahepatic Cholangiocarcinoma (Training) | A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC) Receives: Diagnostic Test: ELUCIDATE | |
| Hepatocellular Carcinoma (Validation) | A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC) Receives: Diagnostic Test: ELUCIDATE | |
| Intrahepatic Cholangiocarcinoma (Validation) | A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC) Receives: Diagnostic Test: ELUCIDATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Specificity
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
Measured: 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)
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Mar 2024
- Primary completion18 Jun 2028 (estimated)
- Study completion18 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ajay Goel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342414
- Sponsor's protocol ID
- 23228/ELUCIDATE
- Acronym
- ELUCIDATE
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
Publications
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.
PubMed 29624699Wu 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.
PubMed 37823913El-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.
PubMed 18471552Vigano 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.
PubMed 32323164Kovac 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.
PubMed 35200560Arbelaiz 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.
PubMed 28555885Banales 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.
PubMed 30325540Huang 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.
PubMed 33570803Chen 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.
PubMed 32289533Foda 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.
PubMed 36399356Lapitz 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.
PubMed 36868481Wang 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.
PubMed 36417488Ye 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.
PubMed 31269959Li 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.
PubMed 29642941Sasaki 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.
PubMed 30897788
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT06342414
- Acronym / sponsor ID
- ELUCIDATE / 23228/ELUCIDATE
- Conditions
- Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Cholangiocarcinoma, Primary Liver Cancer, Primary Liver Carcinoma, Hepatic Cancer
- Keywords
- Exosome, micro RNA, Differential Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 18 Jun 2028 (estimated)
- Study completion
- 18 Jun 2028 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary liver cancers (PLCs) encompass a diverse group of malignancies originating from the liver, collectively ranking as the third leading cause of cancer-related mortality worldwide in 2020. Among PLCs, intrahepatic cholangiocarcinoma (ICC) and hepatocellular carcinoma (HCC) represent the most predominant subtypes. Despite their collective grouping as PLCs, ICC and HCC patients exhibit distinct etiologies, pathologies, and clinical characteristics, necessitating different treatment approaches. Accurate differentiation between ICC and HCC is paramount to optimize patient outcomes and guide personalized treatment decisions. However, a definitive diagnosis is often obtained only after the pathological review of the resected neoplastic tissue, which requires invasive tumor sampling and poses risks of complications such as hemorrhage and tumor cell seeding. Consequently, there is a pressing clinical need to develop noninvasive diagnostic approaches to achieve an accurate differential diagnosis for patients with these distinct forms of PLCs.
This study involves the development and validation of a liquid biopsy, assessing circulating exosomal microRNAs (exo-miRNA) for indirect sampling of tumor tissue in the bloodstream. The researchers intend to harness machine learning and bioinformatics to create a cost-efficient, non-invasive, clinic-friendly assay with high sensitivity and specificity, aiding the differential diagnosis between ICC and HCC.
The researchers intend to do so in three phases:
- To perform comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC.
- To develop and train a differential diagnosis panel based on advanced machine-learning models to obtain a final differential diagnosis biomarker.
- To validate the findings in an independent cohort of ICC and HCC.
In summary, this proposal promises to improve patient care and help clinicians perform a more reliable differential diagnosis between ICC and HCC in patients with primary liver cancer.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular Carcinoma (Training) | – | Diagnostic Test: ELUCIDATEA cohort of patients with histologically confirmed hepatocellular carcinoma (HCC) |
| Intrahepatic Cholangiocarcinoma (Training) | – | Diagnostic Test: ELUCIDATEA cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC) |
| Hepatocellular Carcinoma (Validation) | – | Diagnostic Test: ELUCIDATEA cohort of patients with histologically confirmed hepatocellular carcinoma (HCC) |
| Intrahepatic Cholangiocarcinoma (Validation) | – | Diagnostic Test: ELUCIDATEA cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who were diagnosed with either intrahepatic cholangiocarcinoma or hepatocellular carcinoma (case-case design for a differential diagnosis study)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELUCIDATEAlso: ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic) | Diagnostic test | Hepatocellular Carcinoma (Training), Hepatocellular Carcinoma (Validation), Intrahepatic Cholangiocarcinoma (Training), Intrahepatic Cholangiocarcinoma (Validation) |
Primary outcome
Sensitivity
Time frame: Through study completion, an average of 1 year
True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive
2 secondary outcomes
Specificity
Time frame: 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)
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 29624699Marrero 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.
- Background: PubMed 37823913Wu 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.
- Background: PubMed 18471552El-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.
- Background: PubMed 32323164Vigano 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.
- Background: PubMed 35200560Kovac 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.
- Background: PubMed 28555885Arbelaiz 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.
- Background: PubMed 30325540Banales 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.
- Background: PubMed 33570803Huang 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.
- Background: PubMed 32289533Chen 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.
- Background: PubMed 36399356Foda 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.
- Background: PubMed 36868481Lapitz 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.
- Background: PubMed 36417488Wang 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.
- Individual participant dataSharing planned: Undecided. Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ajay Goel, PhD principal investigator
City of Hope Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma, run by City of Hope Medical Center at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ajay Goel, PhD (6262183452, AJGOEL@COH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06342414, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.