Characteristic and Survival Outcomes in Hepatocellular Carcinoma Patients: on Top of Viral Hepatitis Versus Combined Viral and Metabolic-Associated Steatotic Liver Disease

March 7, 2025 updated by: Sara Mamdouh Ali kamel Ibrahim Badary, Assiut University

Hepatocellular carcinoma (HCC) is one of the most prevalent cancers globally and ranks as the third leading cause of cancer-related deaths . It primarily arises in patients with chronic liver disease and liver cirrhosis, which can result from various etiologies, including viral hepatitis and metabolic disorders. Viral hepatitis, especially Hepatitis B virus (HBV) and Hepatitis C virus (HCV), is well-established as a major risk factor for HCC. Chronic HBV infection is associated with a higher risk of HCC, particularly in areas with high endemicity . Similarly, HCV is linked to significant liver-related morbidity and mortality, with HCC being a leading complication .

In recent years, the increasing prevalence of metabolic-associated steatotic liver disease (MASLD) has emerged as a significant contributor to liver disease and HCC, particularly in the context of the obesity epidemic. MASLD is characterized by fatty liver disease associated with metabolic risk factors such as obesity, insulin resistance, and type 2 diabetes . The combination of chronic viral hepatitis and MASLD may exacerbate liver damage and contribute to the development of HCC, although the specific mechanisms remain to be fully elucidated Despite the known associations between these risk factors and HCC, there remains a shortage of comprehensive studies comparing the clinical characteristics and survival outcomes of patients with HCC due to viral hepatitis alone versus those with combined viral and MASLD. Understanding these differences is crucial for optimizing surveillance, treatment strategies, and prognostic assessment for patients at risk of HCC.

the aim of the study Compare the clinical characteristics of HCC patients with viral hepatitis versus those with combined viral and MASLD.

- Analyze survival outcomes in both groups and correlate these outcomes with patients' characteristics.

Study Overview

Status

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

150

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

HCC patients divided into two group:

  • Group 1: HCC patients with viral hepatitis alone (HBV or HCV).
  • Group 2: HCC patients with combined viral hepatitis (HBV or HCV) and MASLD.

Description

Inclusion Criteria:

  • Adults (≥18 years old) diagnosed with HCC based on radiological, histological (if needed), or biomarker criteria (e.g., elevated AFP).

    . Documented history of:

  • Chronic Hepatitis B virus (HBV) infection or Hepatitis C virus (HCV) infection.
  • MASLD defined as hepatic steatosis (≥5%) confirmed by FibroScan or abdominal ultrasound along with at least one metabolic risk factor (e.g., obesity, type 2 diabetes, hypertension).

Ability to provide informed consent

Exclusion Criteria:

  • . Other causes of chronic liver disease (e.g., autoimmune hepatitis, hemochromatosis, Wilson's disease).
  • Patients with incomplete clinical or diagnostic data.
  • Presence of other malignancies.
  • Patients refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Group 1
HCC patients with viral hepatitis alone (HBV or HCV).
Group 2
HCC patients with combined viral hepatitis (HBV or HCV) and MASLD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 1 year
Comparison of overall survival between HCC patients with viral hepatitis alone and those with combined viral hepatitis and MASLD, measured from diagnosis to death or last follow-up.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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