Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07265271

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

Led by City of Hope Medical Center · Updated on 2026-06-05

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Hepatocellular carcinoma (HCC) is a common and serious form of liver cancer, often diagnosed at an advanced stage which leads to poor survival rates. Early detection is crucial as early-stage HCC can have significantly better outcomes with curative treatments. This study focuses on developing a new multi-omics liquid biopsy test that analyzes various types of non-coding RNAs to improve accurate early detection of HCC, especially in patients with different liver disease backgrounds. The study involves collecting blood and other biological samples from three groups: patients diagnosed with HCC, patients with chronic liver disease but no HCC, and healthy individuals without liver disease or cancer. Researchers will perform comprehensive small RNA sequencing and PCR-based tests to identify and validate biomarkers that distinguish early-stage HCC from other liver conditions. Advanced machine learning techniques will be used to build a diagnostic classifier based on circulating small RNAs. Participants will provide biospecimens and clinical data while undergoing standard diagnostic and staging procedures. The research team will assess the diagnostic performance of the multi-omics biomarker panel at baseline and validate the model in independent patient groups. They will also explore specific biomarker profiles related to different causes of HCC. Overall, this study aims to improve non-invasive early detection methods for HCC to guide timely and effective treatment decisions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 100 years
  • Histologically confirmed hepatocellular carcinoma diagnosis
  • Clinical diagnosis of chronic liver disease, including chronic hepatitis or liver cirrhosis, without hepatocellular carcinoma
  • Healthy volunteers without known liver disease or malignancy
  • Received standard diagnostic and staging procedures as per local guidelines
  • Availability of blood or other biospecimens
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed consent
  • History of other active cancers within the past 5 years
  • Previous liver transplantation
  • Severe systemic infection or inflammatory disease at enrollment
  • Inadequate quality or quantity of samples

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants provide blood or other biospecimens for multi-omics profiling to identify biomarkers distinguishing hepatocellular carcinoma, chronic liver disease, and healthy controls.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

City of Hope Medical Center

Duarte, California, United States, 91016

Actively Recruiting

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Research Team

G

Goel Ajay, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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Published Research Related To This Trial

Protein induced by vitamin K absence or antagonist-II versus alpha-fetoprotein in the diagnosis of hepatocellular carcinoma: A systematic review with meta-analysis.

Hao Xing, Yi-Jie Zheng, Jun Han...

https://pubmed.ncbi.nlm.nih.gov/30257796