Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07265271
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Small RNA sequence — DIAGNOSTIC_TEST
    Comprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC.
  • Rt-qPCR — DIAGNOSTIC_TEST
    Construction of integrated cf- tsmiRNAs diagnostic classifier using machine learning
  • Rt-qPCR — DIAGNOSTIC_TEST
    PCR-based validation of the tsRNA panel

Study Details

Hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage, and early detection is critical for improving patient outcomes. Despite this, reliable non-invasive biomarkers for early-stage HCC are limited. This study seeks to develop a multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.

Key Dates

Start date
Jan 15, 2025
Status verified
Jun 2026
Primary completion
Jun 18, 2026
Completion
Jun 18, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: HCC (Discovery, Small RNA-seq)
    Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling
  • Arm: Chronic Liver Disease (CLD) cohort
    Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma. Blood or other biospecimens will be collected for multi-omics profiling.
  • Arm: Healthy Controls
    Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.

Primary Outcome Measure

Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection [ Time Frame: At the baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91016
Ajay Goel, PhD
[email protected]
626-218-3452

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By research site
City of Hope Medical Center· Duarte, CA

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