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

NCT ID: NCT06325826

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

General Evaluation Score (GES)

Intervention Type DIAGNOSTIC_TEST

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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Liver Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Egyptian Liver Hospital

Ţalkhā, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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GES

Identifier Type: -

Identifier Source: org_study_id

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