Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH

NCT06813508 | Recruiting

• 1 other identifier: BOMASH
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metabolic Dysfunction-Associated Steatotic Liver Disease; Hepatocellular Carcinoma; Metabolic Dysfunction-Associated Steatohepatitis; Liver Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of HCC and liver transplantation (OLT)

  From enrollment to november 2044

• Response rate in patients

  From enrollment to november 2044

• Number of cases of liver complications

  From enrollment to november 2044

• Response to dietologic and pharmacological therapies related to glycated hemoglobin levels

  From enrollment to november 2044

• Response to dieto-therapeutic and pharmacological therapies related to weight

  From enrollment to november 2044

Study Arms (2)

Prospective Cohort

MASLD/MASH patients prospectivelly enrolled.

Retrospective Cohort

MASLD/MASH patients retrospectivelly enrolled.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

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 Officials

• Fabio Piscaglia, Prof, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Piscaglia, MD

CONTACT

+39 051 2142542; fabio.piscaglia@unibo.it

Federico Ravaioli, MD PhD

CONTACT

+39 0512142717; f.ravaioli@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 7, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 20, 2043
• Study Completion (Estimated): November 20, 2044
• Last Updated: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)