Predictors of HCC in Post-HCV Cirrhotic Patients After SVR

NCT ID: NCT07097870

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-11-30

Brief 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.

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

Conditions

HCC - Hepatocellular Carcinoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cases

SVR patients who developed HCC

No interventions assigned to this group

Controls

SVR patients who did not develop HCC

No interventions assigned to this group

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Zakaria Saeed Gerges Awad

Internal Medicine Resident Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Usama A Arafa, PhD

Role: STUDY_CHAIR

Faculty of Medicine, Sohag university

Ali M Hussein, PhD

Role: STUDY_DIRECTOR

Faculty of Medicine, Sohag university

Locations

Faculty of Medicine, Sohag Univesity

Sohag, , Egypt

Countries

Egypt

Central Contacts

Zakaria S Gerges, MBBS

Role: CONTACT

zakaria_saeed_post@med.sohag.edu.eg

+201017718950

Facility Contacts

Zakaria S Gerges, MBBS

Role: primary

zakaria_saeed_post@med.sohag.edu.eg

+201017718950

Other Identifiers

Soh-Med--25-7-12MS

Identifier Type: -

Identifier Source: org_study_id