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

April 1, 2024 updated by: City of Hope Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. To perform comprehensive small RNA-Seq from exo-miRNA from patients with ICC and HCC.
  2. To develop and train a differential diagnosis panel based on advanced machine-learning models to obtain a final differential diagnosis biomarker.
  3. 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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuoka, Japan
        • Recruiting
        • Graduate School of Medical Sciences, Kyushu University
        • Contact:
          • Tomoharu Yoshizumi
        • Sub-Investigator:
          • Tomoharu Yoshizumi
        • Sub-Investigator:
          • Takeo Toshima
      • Kumamoto, Japan
        • Recruiting
        • Graduate School of Medical Sciences, Kumamoto University
        • Contact:
          • Hideo Baba
        • Sub-Investigator:
          • Hideo Baba
      • Sapporo, Japan
        • Recruiting
        • Hokkaido University Graduate School of Medicine
        • Contact:
          • Akinobu Taketomi
        • Principal Investigator:
          • Akinobu Taketomi
        • Principal Investigator:
          • Yoh Asahi
        • Sub-Investigator:
          • Tatsuhiko Kakisaka
      • Tokushima, Japan
        • Recruiting
        • Tokushima University
        • Sub-Investigator:
          • Katsuki Miyazaki
        • Contact:
          • Mitsuo Shimada
        • Sub-Investigator:
          • Mitsuo Shimada
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Ajay Goel, PhD
        • Sub-Investigator:
          • Caiming Xu, MD, PhD
        • Principal Investigator:
          • Yoh Asahi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals who were diagnosed with either intrahepatic cholangiocarcinoma or hepatocellular carcinoma (case-case design for a differential diagnosis study)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatocellular Carcinoma (Training)
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
Diagnostic test: ELUCIDATE
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Other Names:
  • ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Intrahepatic Cholangiocarcinoma (Training)
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
Diagnostic test: ELUCIDATE
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Other Names:
  • ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Hepatocellular Carcinoma (Validation)
A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
Diagnostic test: ELUCIDATE
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Other Names:
  • ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Intrahepatic Cholangiocarcinoma (Validation)
A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
Diagnostic test: ELUCIDATE
ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)
Other Names:
  • ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: Through study completion, an average of 1 year
True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative
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
A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Ajay Goel, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/ELUCIDATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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