Actively Recruiting
Prognostic Factors for the Development of Hepatocellular Carcinoma and Liver Transplantation in Patients With Metabolic Liver Diseases (MASLD/MASH): The BOMASH Study
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-07
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting the BOMASH study, a single-center observational research project focusing on patients with Metabolic-Associated Steatotic Liver Disease (MASLD) and Metabolic-Associated Steatohepatitis (MASH). The study aims to identify predictive factors and biomarkers that can help determine the risk of developing liver complications, including hepatocellular carcinoma (HCC) and the need for liver transplantation. This study includes both newly diagnosed patients and those already under follow-up or routine care at the center. The study does not involve any pharmacological treatments and includes two groups of MASLD/MASH patients: those prospectively enrolled and those retrospectively enrolled. It relies on collecting data through routine diagnostic and therapeutic care, including the use of non-invasive tests and liver biopsies when clinically indicated. The research hopes to use this data to improve risk stratification and support targeted management for patients at higher risk of severe liver disease. Participants will be monitored over a long period, from enrollment until November 2044, with regular data collection on outcomes such as the number and timing of HCC cases and liver transplants. Researchers will also track responses to diet and pharmacological therapies, biochemical changes, and the progression of liver complications. This comprehensive follow-up aims to provide valuable prognostic information to improve care planning and healthcare sustainability for metabolic liver disease patients.
CONDITIONS
Brief Title
Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients diagnosed with MASLD according to the most recent published guidelines (EASL, EASD, EASO)
- Age 18 years or older
- Patients requiring liver biopsy for diagnostic purposes as indicated by recent published guidelines (EASL, EASD, EASO)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on diagnostic schedule
Participants undergo diagnostic procedures including liver biopsy and non-invasive tests to assess the severity and progression of metabolic liver disease.
1 to 2 visits depending on diagnostic needs
Duration - Up to 21 years
Participants are observed over time to track disease progression, development of hepatocellular carcinoma (HCC), and the need for liver transplantation as part of routine care.
Periodic visits as part of routine diagnostic and therapeutic care
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Fabio Piscaglia, MD
F
Federico Ravaioli, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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