Cell-free tsRNA signature to detect early liver cancer
A Cell-Free tsRNA-Based Liquid Biopsy Signature for Early Detection of Hepatocellular Carcinoma
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Duarte, California) |
| Trial ID | NCT07265271 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A histologically confirmed diagnosis of hepatocellular carcinoma. * Received standard diagnostic and staging procedures as per local guidelines * Availability of at least one blood-derived sample, drawn before receiving any curative-intent treatment Exclusion Criteria: • Lack of or inability to provide informed consent
Where this trial is running
Duarte, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.