Recruiting

cf-tsRNA

Sponsor:

City of Hope Medical Center

Code:

NCT07265271

Conditions

Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Small RNA sequence

Rt-qPCR

Rt-qPCR

Study Details

Brief 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 multi-omics-based liquid biopsy assay, especially focusing on ncRNAs (e.g. tsRNA, miRNA, circRNA, lncRNA, etc.) for accurate detection of early-stage HCC.

Conditions

Hepatocellular Carcinoma (HCC)

Study ID

NCT07265271

Start date

Jan 15, 2025

Status verified date

Jun, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

HCC (Discovery, Small RNA-seq)

Patient diagnosed with hepatocellular carcinoma, including cases with HBV-, HCV-, and NBNC-related etiologies. Blood or other biospecimens will be collected for multi-omics profiling

Chronic Liver Disease (CLD) cohort

Patients with chronic liver disease, including liver cirrhosis and chronic hepatitis, without evidence of hepatocellular carcinoma.

Blood or other biospecimens will be collected for multi-omics profiling.

Healthy Controls

Healthy individuals without known liver disease or malignancy who will provide blood or other biospecimens as normal controls for biomarker evaluation.

Interventions

Small RNA sequence

Comprehensive small RNA sequencing of serum or plasma-derived cf-tsRNAs to identify candidate biomarkers distinguishing HCC from NDC.

Rt-qPCR

Construction of integrated cf- tsmiRNAs diagnostic classifier using machine learning

Rt-qPCR

PCR-based validation of the tsRNA panel

Primary outcome measure

  • Diagnostic performance of the integrated multi-omics signature for hepatocellular carcinoma detection [ Time Frame: At the baseline ]

Central Contacts and Locations

Central contacts

Goel Ajay, PhD

626-218-3452ajgoel@coh.org

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91016

Contacts

Ajay Goel, PhD

626-218-3452ajgoel@coh.org

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • HCC
  • Liver cancer
  • tsRNA
  • Liquid Biopsy
  • Early Detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-01.