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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 5 sites (Duarte, California and 4 other locations) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT06342414 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.