NCT07265271 · City of Hope Medical Center
Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
(CENTINEL)
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Small RNA sequence
Comprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC.
DIAGNOSTIC_TEST
Rt-qPCR
Construction of integrated cf- tsmiRNAs diagnostic classifier using machine learning
DIAGNOSTIC_TEST
Rt-qPCR
PCR-based validation of the tsRNA panel
Primary outcome measures
Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection
Time frame: At the baseline
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Received standard diagnostic and staging procedures as per local guidelines
- Availability of blood or other biospecimens.
- Ability to provide written informed consent.
Exclusion criteria
- 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
- Inadequate sample quality or quantity
Where
- Duarte, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations