Plasma MicroRNA for Prediction of Hepatocellular Carcinoma

July 5, 2022 updated by: Amr M. El Hammady, Benha University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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- Qalyobia
      • Banhā, El- Qalyobia, Egypt, 13511
        • Benha University

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

27 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HCV patients

Description

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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Complicated HCV
Biological: Blood Sampling
Blood sampling under a complete aseptic conditions
Non Complicated HCV
Biological: Blood Sampling
Blood sampling under a complete aseptic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between MicroRNA and HCV
Time Frame: 12 months
The ability of estimation of plasma microRNA 21 and 126 to differentiate between uncomplicated and complicated HCV patients
12 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)

May 13, 2021

Primary Completion (Actual)

December 7, 2021

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

July 5, 2022

First Submitted That Met QC Criteria

July 5, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 1.7.2021

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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