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

NCT06871930 | Not Yet Recruiting DMC

• 1 other identifier: HCC viral Vs MASLD hepatitis
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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

Study Arms (2)

Group 1

HCC patients with viral hepatitis alone (HBV or HCV).

Group 2

HCC patients with combined viral hepatitis (HBV or HCV) and MASLD.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03