NCT06325826

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 16, 2024

Last Update Submit

March 22, 2024

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Hepatocellular Carcinoma

    Number of Participants develop New Hepatocellular Carcinoma

    24 month

Study Arms (1)

Group 1

Diagnostic Test: General Evaluation Score (GES)

Interventions

General Evaluation Score (GES)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)

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptian Liver Hospital

Ţalkhā, Dakahlia Governorate, 36681, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 22, 2024

Study Start

February 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2025

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

EG(1)