Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07404566

Enrollment

Registered

2026-02-11

Start date

2025-08-15

Completion date

2025-12-25

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Brief summary

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).

Interventions

DIAGNOSTIC_TESTPCR

PCR quantification of plasma microRNA levels (MiR-21, 1246, 205, 29a-3p, and 497).

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma	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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026