Identifying Prognostic Factors for Liver Disease and Transplant Needs
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
This study is trying to find out which factors can help predict if people with certain liver diseases will need a transplant or develop liver cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06813508 on ClinicalTrials.gov |
What this trial studies
The BOMASH study is an observational study that aims to identify predictive factors related to the prognosis of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). It will include patients diagnosed with these conditions, whether newly diagnosed or previously identified, to uncover biomarkers that indicate the risk of requiring a liver transplant or developing hepatocellular carcinoma (HCC). The study will utilize a combination of non-invasive tests and serum biomarkers to enable effective risk stratification for patients at the highest risk of progression.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with MASLD or MASH.
Not a fit: Patients without a diagnosis of MASLD or MASH will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and targeted treatments for patients with metabolic liver diseases.
How similar studies have performed: While similar studies have explored prognostic factors in liver diseases, this specific approach focusing on MASLD/MASH and non-invasive risk stratification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Piscaglia, Prof, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Fabio Piscaglia, MD
- Email: fabio.piscaglia@unibo.it
- Phone: +39 051 2142542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.