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OpenTrials
Completed

NCT Number: NCT07404566

Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in 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).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria Faculty of medicine

Alexandria, El Alexandria, 21512, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCR

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Diagnostic Performance for LC

    Time frame: Around 3 months

    Differentiating liver cirrhosis using downregulated MiR-205 and overexpressed MiR-29a.

  2. Biomarker Correlation

    Time frame: Around 3 months

    Correlation between miRNA levels and serum Alpha-Fetoprotein (AFP).

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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