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
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.
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
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 →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.
post-HCV cirrhotic patient from Egypt, after achieving SVR 12 (between 2016-2019) who did (cases) or did not (controls) develop HCC
for cases:
Exclusion Criteria:
for cases:
SVR patients who developed HCC
SVR patients who did not develop HCC
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)
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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Sohag University