Actively Recruiting

Age: 18Years +
All Genders
ID06342414

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

Led by City of Hope Medical Center · Updated on 2026-04-03

400

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Primary liver cancers, including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), are serious diseases that require accurate diagnosis for proper treatment. These two cancer types have different causes and characteristics, making it important to distinguish between them before surgery. This research aims to develop and validate a non-invasive liquid biopsy test using exosomal microRNAs and machine learning to help doctors differentiate HCC from ICC without needing risky tissue sampling. The study will analyze blood samples from patients with confirmed HCC or ICC to identify distinct exosomal microRNA patterns. It will follow three phases: first, performing detailed RNA sequencing from blood exosomes; second, creating a machine learning model to develop a diagnostic panel; and third, validating this panel in an independent group of patients. This approach hopes to offer a cost-effective and clinic-friendly test called ELUCIDATE for better diagnosis of these liver cancers. Participants will provide blood samples before any curative treatment and undergo standard diagnostic procedures. Researchers will measure how accurately the test can identify the correct cancer type by assessing its sensitivity, specificity, and overall accuracy. The study will monitor these outcomes over about one year to ensure the test's reliability and safety for future clinical use.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of hepatocellular carcinoma
  • Histologically confirmed diagnosis of intrahepatic cholangiocarcinoma
  • Received standard diagnostic and staging procedures according to local guidelines
  • Availability of at least one blood sample taken before any curative-intent treatment
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • Presence of both hepatocellular carcinoma and intrahepatic cholangiocarcinoma at the same time
  • Primary liver cancer type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma
  • Secondary liver cancer (cancer spread from another site to the liver)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for blood sample collection before any treatment

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo blood sample analysis using a liquid biopsy to differentiate between subtypes of primary liver cancer.

Periodic blood sample collections as part of standard diagnostic procedures

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored to validate the diagnostic accuracy of the liquid biopsy over time.

Follow-up assessments coordinated with routine care visits

Trial Site Locations

Total: 5 locations

1

City of Hope Medical Center

Duarte, California, United States, 91010

Actively Recruiting

2

Graduate School of Medical Sciences, Kyushu University

Fukuoka, Japan

Actively Recruiting

3

Graduate School of Medical Sciences, Kumamoto University

Kumamoto, Japan

Actively Recruiting

4

Hokkaido University Graduate School of Medicine

Sapporo, Japan

Actively Recruiting

5

Tokushima University

Tokushima, Japan

Actively Recruiting

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Research Team

A

Ajay Goel, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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Published Research Related To This Trial

Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases.

Jorge A Marrero, Laura M Kulik, Claude B Sirlin...

https://pubmed.ncbi.nlm.nih.gov/29624699

Diagnostic performance of magnetic resonance imaging and contrast-enhanced ultrasound in differentiating intrahepatic cholangiocarcinoma from hepatocellular carcinoma: a meta-analysis.

Yingyi Wu, Chunchao Xia, Jie Chen...

https://pubmed.ncbi.nlm.nih.gov/37823913

Imaging Spectrum of Intrahepatic Mass-Forming Cholangiocarcinoma and Its Mimickers: How to Differentiate Them Using MRI.

Jelena Djokic Kovač, Aleksandra Janković, Aleksandra Đikić-Rom...

https://pubmed.ncbi.nlm.nih.gov/35200560

Serum extracellular vesicles contain protein biomarkers for primary sclerosing cholangitis and cholangiocarcinoma.

Ander Arbelaiz, Mikel Azkargorta, Marcin Krawczyk...

https://pubmed.ncbi.nlm.nih.gov/28555885

Serum Metabolites as Diagnostic Biomarkers for Cholangiocarcinoma, Hepatocellular Carcinoma, and Primary Sclerosing Cholangitis.

Jesus M Banales, Mercedes Iñarrairaegui, Ander Arbelaiz...

https://pubmed.ncbi.nlm.nih.gov/30325540

Utility of Liquid Biopsy Analysis in Detection of Hepatocellular Carcinoma, Determination of Prognosis, and Disease Monitoring: A Systematic Review.

Vincent L Chen, Dabo Xu, Max S Wicha...

https://pubmed.ncbi.nlm.nih.gov/32289533