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NCT Number: NCT06871930

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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