Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients

February 10, 2026 updated by: Raafat R. Mohammed, Benha University

The Merits of Implementing microRNAs for Diagnosing Hepatocellular Carcinoma Among Hepatitis C Patients

This study evaluates a target population of patients with Hepatitis C virus (HCV) infection, including those with complications like liver cirrhosis (LC) and hepatocellular carcinoma (HCC), to investigate the diagnostic utility of a specific panel of microRNAs (miRNAs). The intervention involves quantifying the plasma expression (PE) levels of MiR-21, 1246, 205, 29a-3p, and 497 via PCR and comparing them to healthy controls to determine their efficacy as biomarkers. The primary outcome is to assess the sensitivity, specificity, and overall accuracy of these miRNAs in differentiating HCC from cirrhotic and non-cirrhotic HCV cases, aiming to establish more reliable screening tools than current standard biomarkers like alpha-fetoprotein (AFP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Alexandria
      • Alexandria, El Alexandria, Egypt, 21512
        • Alexandria Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals attending outpatient clinics for new or chronic HCV follow-up, and healthy volunteers from blood banks, primarily located in Egypt.

Description

Inclusion Criteria:

  • Newly diagnosed HCV infection.
  • Chronic uncomplicated HCV infection.
  • HCV complicated with liver cirrhosis.
  • HCV complicated with HCC on top of cirrhosis.
  • Willingness to participate and sign written informed consent.

Exclusion Criteria:

  • Advanced stage of hepatic cirrhosis with portal hypertension or hepatorenal failure.
  • Hepatic malignancies other than HCC.
  • Bilharzial pre-portal fibrosis.
  • Alcoholic fatty liver disease
  • hepatosteatosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCV Group
21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC.
Diagnostic test: PCR
PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).
LC Group
21 patients with HCV complicated by liver cirrhosis.
Diagnostic test: PCR
PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).
HCC Group
21 patients with HCV complicated by hepatocellular carcinoma.
Diagnostic test: PCR
PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).
Control Group
21 healthy volunteers who passed pre-donation investigations at a Blood Bank.
Diagnostic test: PCR
PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma
Time Frame: Around 3 months
iagnostic utility (sensitivity, specificity, and accuracy rate) of estimated plasma expression (PE) levels of microRNAs (specifically Mir-1246, Mir-21, and Mir-497) to distinguish HCC from LC and HCV
Around 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance for LC
Time Frame: Around 3 months
Differentiating liver cirrhosis using downregulated MiR-205 and overexpressed MiR-29a.
Around 3 months
Biomarker Correlation
Time Frame: Around 3 months
Correlation between miRNA levels and serum Alpha-Fetoprotein (AFP).
Around 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E/C.S/N.R15/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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