Predictors of HCC in Post-HCV Cirrhotic Patients After SVR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HCC - Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Clinical and Laboratory Predictors of Hepatocellular Carcinoma in Post-HCV Cirrhotic Patients After Sustained Virologic Response.
Overview
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.
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
Primary outcome measures
- occurrence of hepatocellular carcinoma (HCC) [Time frame: from SVR12 achievement to 6-9 years later (time of data collection)]
Eligibility criteria
Inclusion criteria
- for cases:
- age ≥ 18 y;
- HCV related cirrhosis;
- SVR12 after DAA;
- radiologic or histologic HCC diagnosis ≤30 Jun 2025
- for controls: As above plus, ≥36 months post SVR without HCC
Exclusion criteria
- for cases:
- non HCV cirrhosis or combined HCV-HBV cirrhosis;
- HCC <6 months before SVR;
- concomitant cholangiocarcinoma
- for controls: Same as cases, plus, loss to follow up before 36 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Egypt · 1 center
- Faculty of Medicine, Sohag Univesity — Sohag
Identifiers
NCT: NCT07097870 · Soh-Med--25-7-12MS