Recruiting

Exosome-Based Liquid Biopsy

Sponsor:

City of Hope Medical Center

Code:

NCT06342414

Conditions

Hepatocellular Carcinoma

Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma

Primary Liver Cancer

Primary Liver Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ELUCIDATE

Study Details

Brief 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 before surgery.

Conditions

Hepatocellular Carcinoma

Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma

Primary Liver Cancer

Primary Liver Carcinoma

Study ID

NCT06342414

Start date

Mar 15, 2024

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Hepatocellular Carcinoma (Training)

A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)

Intrahepatic Cholangiocarcinoma (Training)

A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)

Hepatocellular Carcinoma (Validation)

A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)

Intrahepatic Cholangiocarcinoma (Validation)

A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)

Interventions

ELUCIDATE

ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)

Primary outcome measure

  • Sensitivity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Ajay Goel, PhD

6262183452AJGOEL@COH.ORG

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Ajay Goel, PhD

626-218-3452AJGOEL@COH.ORG

Principal Investigator:

Yoh Asahi, MD

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Exosome
  • micro RNA
  • Differential Diagnosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.