The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs

March 22, 2024 updated by: Egyptian Liver Hospital
This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

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
    • Dakahlia
      • Talkha, Dakahlia, Egypt, 36681
        • Egyptian liver hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved SVR for HCV after DAAs

Description

Inclusion Criteria:

  • Adult patients aged 18 years or older.
  • Patients with compensated advanced chronic liver disease (cACLD) according to Baveno VI consensus (F3-F4)
  • achieved SVR for HCV after DAAs.

Exclusion Criteria:

  • Previous interferon (IFN) treatment.
  • Hepatitis B virus (HBV) or human immune-deficiency virus (HIV) co-infection.
  • Current hepatocellular carcinoma (HCC) or other malignancies.
  • Previous history of HCC or HCC intervention.
  • Liver cell failure, liver transplantation or renal impairment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Diagnostic test: General Evaluation Score (GES)
According to Evaluation of GES scores Patient will be classified into three groups based on GES score low risk group (score ≤6 points), intermediate risk group (score 6-7.5 points), and high-risk group (score >7.5 points)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatocellular Carcinoma
Time Frame: 24 month
Number of Participants develop New Hepatocellular Carcinoma
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egyptian Liver Hospital

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)

February 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 16, 2024

First Submitted That Met QC Criteria

March 16, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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