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Not yet recruitingNCT07097870Updated Aug 5, 2025

Predictors of HCC in Post-HCV Cirrhotic Patients After SVR

An observational study in HCC - Hepatocellular Carcinoma, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by Sohag University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to identify clinical and laboratory factors that predict the occurrence of hepatocellular carcinoma (HCC) in Egyptian cirrhotic patients after achieving a sustained virologic response (SVR) to hepatitis C virus (HCV) treatment. This is a retrospective, two-center, case-control study that will include 132 cases and 264 controls. Variables to be analyzed include demographics, liver disease status, metabolic comorbidities, lifestyle factors, medications, as well as laboratory parameters and non-invasive scoring systems.

Read the detailed description

Introduction:

Hepatocellular carcinoma (HCC) is a highly fatal cancer with a global 5-year survival rate of less than 20%. In Egypt, HCC is the most common cancer in men and the leading cause of cancer-related death, primarily due to the historically high prevalence of Hepatitis C Virus (HCV). While sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy significantly reduces the risk of HCC, it can still occur, especially in patients with advanced fibrosis or cirrhosis. This necessitates continued HCC surveillance post-HCV cure.

Aim of Work:

To study various clinical and laboratory predictors of hepatocellular carcinoma in Egyptian cirrhotic patients after achieving sustained virologic response.

Methodology:

Study Design: Retrospective, two-center case-control study.

Setting \& Period: Two tertiary hepatology centers: Sohag University Hospital and Sohag Oncology Center.

SVR was achieved between January 1, 2016 - December 31, 2019

Participants:

Cases: SVR patients who developed HCC

Inclusion Criteria: (1) age ≥ 18 y; (2) HCV related cirrhosis; (3) SVR12 after DAA; (4) radiologic or histologic HCC diagnosis ≤30 Jun 2025

Exclusion Criteria: (1) non HCV cirrhosis or combined HCV-HBV cirrhosis; (2) HCC \<6 months before SVR; (3) concomitant cholangiocarcinoma

Controls: SVR patients who did not develop HCC Inclusion Criteria: As above plus,

≥36 months post SVR without HCC

Exclusion Criteria: Same as cases, plus loss to follow-up before 36 months

Sample Size: Using Fleiss' formula yields 120 cases \& 240 controls (360 total). Adding 10 % for incomplete charts ⇒ 132 cases \& 264 controls (≈ 400 subjects).

Variables to Study:

Clinical Predictors: Demographics (Age, Sex, Residence), Liver disease status (History of decompensation, Splenomegaly, Time since SVR), Metabolic comorbidities (Diabetes mellitus, Obesity/BMI, Dyslipidemia, HTN), Lifestyle factors (Smoking, Alcohol use), Medications (Statins, Metformin, Aspirin).

Laboratory Predictors: Platelet count, AST, ALT, AST/ALT ratio, Albumin, Total bilirubin, INR, Alpha-fetoprotein (AFP), HbA1c, Creatinine, Urea, GGT, and ALP.

Non-Invasive Scoring Systems: Child-Pugh Score, MELD Score, FIB-4 Score, ALBI Score, APRI, AAR (AST/ALT ratio).

Ethical Considerations: Approved by IRBs of both centers. Waiver of informed consent granted (retrospective chart review, minimal risk).

Duration: 6 months

02

Conditions studied

  • HCC - Hepatocellular Carcinoma

Keywords

  • HCV
  • Sustained virologic response
  • HCC
  • SVR
  • liver cirrhosis
  • DAA
  • Direct acting antivirals
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

post-HCV cirrhotic patient from Egypt, after achieving SVR 12 (between 2016-2019) who did (cases) or did not (controls) develop HCC

Inclusion criteria

  • for cases:

    1. age ≥ 18 y;
    2. HCV related cirrhosis;
    3. SVR12 after DAA;
    4. radiologic or histologic HCC diagnosis ≤30 Jun 2025
  • for controls: As above plus, ≥36 months post SVR without HCC

Exclusion criteria

Exclusion Criteria:

  • for cases:

    1. non HCV cirrhosis or combined HCV-HBV cirrhosis;
    2. HCC \<6 months before SVR;
    3. concomitant cholangiocarcinoma
  • for controls: Same as cases, plus, loss to follow up before 36 months
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cases

    SVR patients who developed HCC

  • Controls

    SVR patients who did not develop HCC

06

What researchers measure

Primary outcomes

  1. occurrence of hepatocellular carcinoma (HCC)

    measure occurrence of HCC in post-HCV liver cirrhosis after achieving SVR, by comparing cases to controls

    Time frame: from SVR12 achievement to 6-9 years later (time of data collection)

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07097870
Lead sponsor
Sohag University
Responsible party
Zakaria Saeed Gerges Awad (Internal Medicine Resident Doctor, Sohag University) — Principal investigator
First posted
Jul 31, 2025
Start date
Aug 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Aug 5, 2025

Study contacts

Zakaria S Gerges, MBBS
Contact
zakaria_saeed_post@med.sohag.edu.eg
+201017718950
Usama A Arafa, PhD
study chair · Faculty of Medicine, Sohag university
Ali M Hussein, PhD
study director · Faculty of Medicine, Sohag university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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