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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 to 100 years.

A histologically confirmed diagnosis of hepatocellular carcinoma.

A clinically diagnosed as chronic liver disease, including chronic hepatitis or liver cirrhosis, without evidence of hepatocellular carcinoma.

Healthy volunteers without known liver disease or malignancy.

Disqualifiers

Lack of or inability to provide informed consent

History of other active malignancies within the past 5 years

Previous liver transplantation

Severe systemic infection or inflammatory disease at the time of enrollment

Trial population

Individuals who were diagnosed with hepatocellular carcinoma. Individuals who were diagnosed with chronic liver disease Healthy donors

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: HCC (Discovery, Small RNA-seq)2 interventions
Group B: Chronic Liver Disease (CLD) cohort2 interventions
Group C: Healthy Controls2 interventions

Trial outcomes

Primary outcomes

1

Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection

To evaluate the diagnostic accuracy of the model for distinguishing patients with hepatocellular carcinoma from chronic liver disease and healthy controls, as assessed by the area under the operating characteristic curve (AUC), sensitivity, and specificity.

Time frame
At the baseline

Secondary outcomes

1

Validation of the diagnostic model in independent cohorts

To assess the reproducibility and generalizability of the diagnostic model using independent validation cohorts.

Time frame
At the baseline
2

Identification of etiology-associated omics profiles in hepatocellular carcinoma

To characterize differences in omics patterns among HBV-, HCV-, and NBNC-related hepatocellular carcinoma cases, using integrated high-throughput multi-omics analysis.

Time frame
At the baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.