Predictors of HCC in Post-HCV Cirrhotic Patients After SVR

NCT07097870 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25-7-12MS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC - Hepatocellular Carcinoma

Keywords

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

Outcome Measures

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

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

Study Arms (2)

Cases

SVR patients who developed HCC

Controls

SVR patients who did not develop HCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Faculty of Medicine, Sohag Univesity

Sohag, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Usama A Arafa, PhD

  Faculty of Medicine, Sohag university

  STUDY CHAIR

• Ali M Hussein, PhD

  Faculty of Medicine, Sohag university

  STUDY DIRECTOR

Central Study Contacts

Zakaria S Gerges, MBBS

CONTACT

+201017718950; zakaria_saeed_post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Resident Doctor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

EG (1)