Identifying Prognostic Factors for Liver Disease and Transplant Needs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• Link between MASH and mitochondrial membrane changes in people having bariatric surgery.

  We will test whether changes in mitochondria-associated membranes (MAMs) in liver cells and blood immune cells are linked to MASH in adults undergoing bariatric surgery.

  Recruiting at 2 sites Hospices Civils de Lyon · Lyon, France and 1 other locations · NCT06868992

• Using machine perfusion to improve liver transplant outcomes for patients with liver cancer

  This study tests whether a special cooling method for liver grafts can help improve transplant success and reduce complications for patients with liver cancer.

  Recruiting Azienda Ospedaliero-Universitaria di Modena · Modena, MO · NCT06236568

• Endoscopic sleeve gastroplasty for people with obesity and MASH

  This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.

  Recruiting at 2 sites Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06138821

• Using cabozantinib to treat liver cancer that has returned after transplant

  This study is testing if cabozantinib can help people with liver cancer that has come back after a liver transplant.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT04204850

• Health profile of MASLD in Kazakhstan and real-world use of Ursosan in Almaty

  This study tests how MASLD appears in adults in Kazakhstan and how Ursosan is used in real-world care for a subgroup in Almaty.

  Recruiting at 7 sites Kazakh Association of Internal Medicine Specialists · Aktobe, Aktobe and 6 other locations · NCT07889999

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.