Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

Hepatitis C Clinical Trial

Official title:

Plasma Expression Levels of MicroRNA-21 Might Help for Detection of HCV Patients Complicated by Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449847
• Other study ID #: RC 1.7.2021
• Status: Completed
• Start date: May 13, 2021
• Est. completion date: March 20, 2022

Study information

• Verified date: July 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index, the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of liver function tests and plasma levels of microRNA 21 and 126.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 67 Years

Eligibility

Inclusion Criteria:

• Complicated hepatitis C by HCC
• Complicated hepatitis C by liver cirrhosis
• Complicated hepatitis C by steatohepatitis
• uncomplicated hepatitis C

Exclusion Criteria:

• pre-portal fibrosis secondary to previous bilharzial disease
• pre-portal fibrosis secondary to alcoholic fatty liver
• The presence of hepatic malignancy other than HCC
• decompensated cirrhosis
• hepatorenal failure
• hepatic manifestations of congestive heart failure.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis C

Intervention

Biological:
• Blood Sampling
Blood sampling under a complete aseptic conditions

Locations

Country	Name	City	State
Egypt	Benha university	Banha	El- Qalyobia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation between MicroRNA and HCV	The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients	12 months