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.
All patients with a diagnosis of MASLD, established according to the most recent published guidelines (EASL, EASD, EASO)
Age ≥18 years
Patients requiring liver biopsy for diagnostic purposes, as indicated by the most recent published guidelines (EASL, EASD, EASO)
No exclusion criteria.
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.
Cohort
Other
Not listed
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.
Incidence of HCC and liver transplantation (OLT)
Calculate the incidence of liver transplantation and the occurrence of HCC for this disease.
Response rate in patients
Objective response rate in patients with HCC or those requiring liver transplantation, measured using RECIST 1.1 criteria.
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.
Response to dietologic and pharmacological therapies related to glycated hemoglobin levels
Positive response to dietetic and drug therapies is measured by glycated hemoglobin levels.
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