Clinical trial · Observational
Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Transplant | — | UNRESOLVED | — |
| Metabolic Dysfunction-Associated Steatohepatitis | — | UNRESOLVED | — |
| Metabolic Dysfunction-Associated Steatotic Liver Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Prospective Cohort
- description
- MASLD/MASH patients prospectivelly enrolled.
- label
- Retrospective Cohort
- description
- MASLD/MASH patients retrospectivelly enrolled.
Primary outcomes (1)
- measure
- Number of hepatocellular carcinoma (HCC) or liver transplantation (OLT) cases and time to onset.
- timeFrame
- From enrollment to november 2044
- description
- 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.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available