Metabolic Dysfunction-Associated Steatotic Liver DiseaseBOMASHNCT06813508
Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Hepatocellular Carcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatocellular Carcinoma, Metabolic Dysfunction-Associated Steatohepatitis
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2024to 20 Nov 2044
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Fabio Piscaglia, Prof, MD, +39 051 2142542, fabio.piscaglia@unibo.it
Mariarosaria Marseglia, Dr., +39 0512142477, mariarosaria.marseglia@aosp.bo.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatocellular Carcinoma, Metabolic Dysfunction-Associated Steatohepatitis, Liver Transplant
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | MASLD/MASH patients prospectivelly enrolled. | |
| Retrospective Cohort | MASLD/MASH patients retrospectivelly enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to november 2044
Secondary outcomes (7)
Incidence of HCC and liver transplantation (OLT)
Calculate the incidence of liver transplantation and the occurrence of HCC for this disease.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to november 2044
Number of HCC or liver transplantation (OLT) cases categorized by MASLD and MASH
Measured: From enrollment to november 2044
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start20 Nov 2024
- Primary completion20 Nov 2043 (estimated)
- Study completion20 Nov 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Piscaglia, Prof, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813508
- Sponsor's protocol ID
- BOMASH
- Acronym
- BOMASH
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06813508
- Acronym / sponsor ID
- BOMASH / BOMASH
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Hepatocellular Carcinoma, Metabolic Dysfunction-Associated Steatohepatitis, Liver Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Nov 2043 (estimated)
- Study completion
- 20 Nov 2044 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –MASLD/MASH patients prospectivelly enrolled. |
| Retrospective Cohort | – | –MASLD/MASH patients retrospectivelly enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of hepatocellular carcinoma (HCC) or liver transplantation (OLT) cases and time to onset.
Time frame: From enrollment to november 2044
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.
7 secondary outcomes
Incidence of HCC and liver transplantation (OLT)
Time frame: From enrollment to november 2044
Response rate in patients
Time frame: From enrollment to november 2044
Number of cases of liver complications
Time frame: From enrollment to november 2044
Response to dietologic and pharmacological therapies related to glycated hemoglobin levels
Time frame: From enrollment to november 2044
Response to dieto-therapeutic and pharmacological therapies related to weight
Time frame: From enrollment to november 2044
Response to dieto-therapeutic and pharmacological therapies related to biochemical parameters
Time frame: From enrollment to november 2044
Number of HCC or liver transplantation (OLT) cases categorized by MASLD and MASH
Time frame: From enrollment to november 2044
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Piscaglia, Prof, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Hepatocellular Carcinoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Piscaglia, MD (+39 051 2142542, fabio.piscaglia@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hepatocellular carcinoma (HCC) or liver transplantation (OLT) cases and time to onset. (time frame: From enrollment to november 2044). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.