Prognostic Factors for HCC and Liver Transplantation in Patients with MASLD/MASH (BOMASH)

Prognostic Factors for the Development of Hepatocellular Carcinoma (HCC) and Indications for Liver Transplantation in Patients with Metabolic Liver Diseases (MASLD/MASH): the BOMASH Study

The BOMASH study is a single-center, prospective/retrospective observational study without pharmacological interventions. It will include all patients diagnosed with Metabolic-Associated Steatotic Liver Disease (MASLD/MASH), whether newly diagnosed or previously identified at the center during follow-up or as part of routine diagnostic and therapeutic care.

The aim of the study is to identify predictive factors related to the prognosis of patients with metabolic liver disease (MASLD/MASH). Specifically, the study seeks to uncover biomarkers that can identify individuals at risk of requiring a liver transplant or developing HCC.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Liver Transplant; Metabolic Dysfunction-Associated Steatohepatitis; Metabolic Dysfunction-Associated Steatotic Liver Disease

Detailed Description

The BOMASH study is a single-center, prospective/retrospective observational study without pharmacological interventions. It will include all patients diagnosed with Metabolic-Associated Steatotic Liver Disease and Metabolic-Associated Steatohepatitis (MASLD/MASH), whether newly diagnosed or previously identified at the center during follow-ups or as part of routine diagnostic and therapeutic care. MASLD is characterized by significant variability in terms of severity and progression rates. Although a large portion of the population is at risk, only a minority develop liver-related comorbidities. Epidemiological studies reveal that patients with MASH have a higher risk of developing liver-related complications compared to those with simple steatosis (MASLD). However, the factors driving progression to MASH and its advanced stages remain unclear, and disease staging can only be accurately determined through liver biopsy. Given the large number of individuals at risk for MASLD, liver biopsy is not a feasible screening tool for widespread use. Key challenges involve understanding the biological and environmental factors that drive variability among MASLD patients and using this knowledge to develop effective methods for risk stratification, enabling targeted treatment for individuals at the highest risk.

The identification of risk factors through the combination of non-invasive tests (serum biomarkers and non-invasive techniques) can enable risk stratification for hepatocellular carcinoma (HCC) development and identify individuals who may require liver transplantation.

A study on MASLD represents a valuable tool to enhance understanding of this nosological entity and to support basic, clinical, and epidemiological research. It also benefits individuals affected by these conditions and assists national and local authorities in planning and optimizing healthcare and social services. Systematic data collection on MASLD can be instrumental in identifying previously unrecognized risk factors that may predispose individuals to more aggressive and treatment-resistant forms of the disease.

Analyzing the collected data could highlight potential common markers among patients whose MASLD diagnosis progresses to HCC and subsequently necessitates liver transplantation. These findings would provide useful prognostic factors for patient management.

In conclusion, the opportunity to longitudinally track disease progression in a large cohort of patients with chronic metabolic liver disease could pave the way for strategies that make the management of this highly prevalent condition more sustainable for national and regional healthcare systems.

Therefore, the aim of the study is to identify predictive factors related to the prognosis of patients with metabolic liver disease (MASLD/MASH). Specifically, the study seeks to uncover biomarkers that can identify individuals at risk of requiring a liver transplant or developing HCC.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Fabio Piscaglia, MD; Phone Number: +39 051 2142542; Email: fabio.piscaglia@unibo.it
• Study Contact Backup: Name: Federico Ravaioli, MD PhD; Phone Number: +39 0512142717; Email: f.ravaioli@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Fabio Piscaglia, Prof, MD; Phone Number: +39 051 2142542; Email: fabio.piscaglia@unibo.it
    • Contact: Mariarosaria Marseglia, Dr.; Phone Number: +39 0512142477; Email: mariarosaria.marseglia@aosp.bo.it
    • Contact: Fabio Piscaglia, Prof., MD
    • Contact: Federico Ravaioli, MD, PhD
    • Contact: Silvia Ferri, MD, PhD
    • Contact: Bernardo Stefanini, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be presented to every patient with a diagnosis of MASLD/MASH, either newly diagnosed or previously diagnosed at the promoting center during follow-ups or routine diagnostic-therapeutic pathways.

Description

Inclusion Criteria:

• All patients with a diagnosis of MASLD, established according to the most recent published guidelines (EASL, EASD, EASO)
• Age ≥18 years

Inclusion Criteria for Biological Sample Collection:

• Patients requiring liver biopsy for diagnostic purposes, as indicated by the most recent published guidelines (EASL, EASD, EASO)

Exclusion Criteria:

• No exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Cohort; MASLD/MASH patients prospectivelly enrolled.
Retrospective Cohort; MASLD/MASH patients retrospectivelly enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hepatocellular carcinoma (HCC) or liver transplantation (OLT) cases and time to onset.	The aim of the study is to identify predictive factors related to the prognosis of patients with liver disease of dysmetabolic origin: Metabolic-Associated Steatotic Liver Disease and Metabolic-Associated Steatohepatitis (MASLD/MASH). Specifically, the aim is to identify markers that can predict individuals who will later require a liver transplant or develop hepatocellular carcinoma.	From enrollment to november 2044

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of HCC and liver transplantation (OLT)	Calculate the incidence of liver transplantation and the occurrence of HCC for this disease.	From enrollment to november 2044
Response rate in patients	Objective response rate in patients with HCC or those requiring liver transplantation, measured using RECIST 1.1 criteria.	From enrollment to november 2044
Number of cases of liver complications	Cases of liver decompensation, major adverse cardiovascular events (MACE), extrahepatic tumors, and liver transplantation, along with their time of onset.	From enrollment to november 2044
Response to dietologic and pharmacological therapies related to glycated hemoglobin levels	Positive response to dietetic and drug therapies is measured by glycated hemoglobin levels.	From enrollment to november 2044
Response to dieto-therapeutic and pharmacological therapies related to weight	Positive response to dietetic and pharmacological therapies is measured by weight loss.	From enrollment to november 2044
Response to dieto-therapeutic and pharmacological therapies related to biochemical parameters	Positive response to dietetic and pharmacological therapies is measured by biochemical parameters (Aspartate amino transferase, Alanina amino transferase).	From enrollment to november 2044
Number of HCC or liver transplantation (OLT) cases categorized by MASLD and MASH		From enrollment to november 2044

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Fabio Piscaglia, Prof, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Estimated): November 20, 2043
• Study Completion (Estimated): November 20, 2044

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Liver Diseases; Fatty Liver
• Other Study ID Numbers: BOMASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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