Utility of MicroRNAs for Diagnosing Hepatocellular Carcinoma in Hepatitis C Patients

NCT07404566 | Completed

• 1 other identifier: E/C.S/N.R15/2025
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Success Rate of Diagnostic Regimens in Identifying Hepatocellular Carcinoma

  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 Outcomes (2)

• Diagnostic Performance for LC

  Around 3 months

• Biomarker Correlation

  Around 3 months

Study Arms (4)

HCV Group

21 patients with newly diagnosed or chronic HCV infection, free of findings suggestive of cirrhosis or HCC.

Diagnostic Test: PCR

LC Group

21 patients with HCV complicated by liver cirrhosis.

Diagnostic Test: PCR

HCC Group

21 patients with HCV complicated by hepatocellular carcinoma.

Diagnostic Test: PCR

Control Group

21 healthy volunteers who passed pre-donation investigations at a Blood Bank.

Diagnostic Test: PCR

Interventions

PCR DIAGNOSTIC_TEST

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

Control Group; HCC Group; HCV Group; LC Group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Alexandria Faculty of medicine

Alexandria, El Alexandria, 21512, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

The study involved the collection of human blood samples, specifically processed into the following formats: Serum: Obtained by collecting blood in clean tubes, allowing it to clot, and centrifuging at 1000 rpm for 10 minutes. Plasma/Supernatant: Collected into EDTA-containing tubes and centrifuged to separate the supernatant. Total RNA: Extracted from the blood samples, specifically including the microRNA fraction for PCR analysis. Storage and Laboratory Processing Serum Storage: Serum samples used for alpha-fetoprotein (AFP) ELISA estimation were kept frozen at -20 °C. RNA Storage: The supernatant for RNA extraction was stored in RNase-free tubes at -80 °C prior to the extraction process. Molecular Analysis: The retained specimens were used for reverse transcription of cDNA and subsequent Real-time RT-qPCR to determine the relative number of Mir copies using the ΔΔCT method.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant consultant of Clinical Pathology

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 11, 2026
• Study Start: August 15, 2025
• Primary Completion: November 25, 2025
• Study Completion: December 25, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

EG (1)