Cell-free tsRNA signature to detect early liver cancer
Official title: Project for Multi-Omics-Based Early Detection of Hepatocellular Carcinoma (PROMETHEA Study)
Run by City of Hope Medical Center · NCT07265271 · Data updated 2026-11-12
This project will test whether a blood test that measures cell-free tsRNAs can detect early-stage hepatocellular carcinoma using samples from people with confirmed HCC.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | June 18, 2028 |
| Study ends | June 18, 2028 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07265271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed hepatocellular carcinoma who have not yet received curative-intent treatment and can provide a pre-treatment blood sample and informed consent.
✕Probably not a fit
People without HCC, those unable to give informed consent, or patients who have already started curative-intent therapy prior to blood collection are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects pre-treatment blood samples from patients with histologically confirmed hepatocellular carcinoma at City of Hope to develop a liquid biopsy based on cell-free tsRNAs. Investigators will use small RNA sequencing to identify candidate cf-tsRNA markers and then validate selected signatures with RT-qPCR. The work aims to produce a sensitive, noninvasive assay to improve detection of early-stage HCC where current markers like AFP have limited sensitivity. Findings will be compared to clinical staging and standard diagnostic work-ups to see how well the cf-tsRNA signature distinguishes early disease.
Why it matters
Potential benefit: If successful, this could enable earlier, noninvasive detection of HCC so more patients can receive curative treatment and have better survival chances.
How similar studies have gone: Related liquid-biopsy approaches using cfDNA and circulating small RNAs (like miRNAs) have shown promise for liver cancer, but cf-tsRNA-based diagnostics are relatively novel and supported mainly by early-stage data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting
Study contacts
- Study coordinator: Goel Ajay, PhD
- Email: ajgoel@coh.org
- Phone: 626-218-3452
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.