A Cell-Free tsRNA-Based Liquid Biopsy Signature for Early Detection of Hepatocellular Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY
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 cell-free tsRNA (cf-tsRNA)-based liquid biopsy assay for accurate detection of early-stage HCC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Goel Ajay, PhD
ajgoel@coh.org
626-218-3452
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2026-06-18
Participants
Target number of participants: 600
Treatments
HCC (Discovery, Small RNA-seq)
Serum and plasma samples from patients with histologically confirmed HCC will be analyzed using small RNA sequencing to identify circulating tsRNAs specifically upregulated in HCC. These tsRNAs will serve as candidates for downstream validation.
Non-disease Control (Discovery, Small RNA-seq)
Serum and plasma samples from individuals without malignant will be analyzed in parallel by small RNA sequencing to identify tsRNAs differentially expressed between HCC and non-disease controls.
HCC (Training, rt-qPCR)
Serum and plasma samples from patients with histologically confirmed HCC will be analyzed using rt-qPCR to test circulating tsRNAs specifically upregulated in HCC.
NDC (Training, rt-qPCR)
Individuals without malignant whose serum/plasma samples will serve as controls to establish baseline tsRNA expression and diagnostic thresholds.
HCC (Testing, rt-qPCR)
Independent HCC cohort used for external validation of the panel to confirm diagnostic performance and reproducibility.
NDC (Testing, rt-qPCR)
Individuals without malignant whose serum/plasma samples will be used for validation of specificity and model robustness.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center