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

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT06342414
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ELUCIDATE — DIAGNOSTIC_TEST
    ELUCIDATE (Evaluation of Liver Cholangiocarcinoma Intrahepatic)

Study Details

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.

Key Dates

Start date
Mar 15, 2024
Status verified
Apr 2026
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Hepatocellular Carcinoma (Training)
    A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
  • Arm: Intrahepatic Cholangiocarcinoma (Training)
    A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)
  • Arm: Hepatocellular Carcinoma (Validation)
    A cohort of patients with histologically confirmed hepatocellular carcinoma (HCC)
  • Arm: Intrahepatic Cholangiocarcinoma (Validation)
    A cohort of patients with histologically confirmed intrahepatic cholangiocarcinoma (ICC)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Ajay Goel, PhD
626-218-3452
Caiming Xu, MD, PhD (SUB_INVESTIGATOR)
Yoh Asahi, MD (PRINCIPAL_INVESTIGATOR)
Ajay Goel, PhD (PRINCIPAL_INVESTIGATOR)

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