Clinical trial Recruiting at 5 sites Observational Ages 18 and up

Liquid biopsy to differentiate types of primary liver cancer

Official title: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer

Run by City of Hope Medical Center · NCT06342414 · Data updated 2026-11-12

This study is testing a new blood test to see if it can tell the difference between two types of liver cancer, hepatocellular carcinoma and intrahepatic cholangiocarcinoma, to help doctors diagnose patients more safely.

More Hepatocellular Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorCity of Hope Medical Center
Academic / other
Locations5 sites (Duarte, California and 4 other locations)
StatusRecruiting
StartedMarch 15, 2024
Main results expectedJune 18, 2028
Study endsJune 18, 2028
Registry record updatedJuly 7, 2026
Trial IDNCT06342414 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with a confirmed diagnosis of either hepatocellular carcinoma or intrahepatic cholangiocarcinoma who have provided a blood sample.

Probably not a fit

Patients with synchronous hepatocellular carcinoma and intrahepatic cholangiocarcinoma or those with other types of primary or secondary liver cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop and validate a non-invasive liquid biopsy that analyzes exosomal microRNAs to differentiate between hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). By utilizing machine learning and bioinformatics, the researchers seek to create a cost-effective and sensitive assay that can provide accurate diagnoses before surgical intervention. The study will involve patients with histologically confirmed diagnoses of either HCC or ICC, who have provided blood samples prior to treatment. This approach addresses the clinical need for a safer diagnostic method compared to traditional invasive tissue sampling.

Why it matters

Potential benefit: If successful, this method could significantly improve the accuracy of liver cancer diagnoses, leading to better-targeted treatments and improved patient outcomes.

How similar studies have gone: Other studies have shown promise in using liquid biopsies for cancer diagnosis, but this specific approach focusing on exosomal microRNAs for liver cancer differentiation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • City of Hope Medical Center
    Duarte, California, United States
    Recruiting
  • Graduate School of Medical Sciences, Kyushu University
    Fukuoka, Japan
    Recruiting
  • Graduate School of Medical Sciences, Kumamoto University
    Kumamoto, Japan
    Recruiting
  • Hokkaido University Graduate School of Medicine
    Sapporo, Japan
    Recruiting
  • Tokushima University
    Tokushima, Japan
    Recruiting

Study contacts

  • Principal investigator: Ajay Goel, PhD — City of Hope Medical Center
  • Study coordinator: Ajay Goel, PhD
  • Email: AJGOEL@COH.ORG
  • Phone: 6262183452

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.