Global Research Initiative for Patients Screening on MASH

NCT05651724 | Recruiting

• 1 other identifier: GOM
• Study Type: observational
• Target: 10,000
• Locations: 10 countries
• Sites: 13

Brief Summary

GRIPonMASH will assist (primary) health care providers clinicians to implement the latest patient care pathway, as described by the European Association for the Study of the Liver (EASL), to identify patients at risk of severe metabolic dysfunction-associated steatotic liver disease (MASLD) and to raise awareness. The primary objective is to implement a transmural patient care pathway, in order to identify patients with MASLD and its progressive form metabolic dysfunction-associated steatohepatitis (MASH) in primary care centres and clinics in 10 European countries.

Conditions

MASH; MASLD; MASH With Fibrosis; Fibrosis, Liver; Steatosis of Liver; Type 2 Diabetes; Obesity; Metabolic Syndrome; Arterial Hypertension

Keywords

MASLD; MASH; Screening; Patient care pathway

Outcome Measures

Primary Outcomes (6)

• Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk

  Steatosis grade deduced from controlled attenuation parameter (CAP) measurement with Fibroscan

  Baseline

• Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk

  Fibrosis stage deduced from liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) measurement with Fibroscan

  Baseline

• Prevalence of at-risk MASH estimated by FAST score in patients at risk

  At-risk MASH deduced from FAST score

  Baseline

• *Subset of patients: prevalence of MASH in patients at risk

  MASH diagnosis confirmed by histology (NAS/SAF criteria) upon liver biopsy; only in patients with \>12 kPa at 1st FibroScan or \>=8 kPa at 2nd FibroScan

  16 or 30 weeks

• Comparison of the prevalence of MASLD, liver fibrosis and (at-risk) MASH between the participating countries

  Prevalence (see outcome 1-4) stratified per country

  Baseline (1-3) to 16/30 weeks for biopsy-confirmed MASH (4)

• Evaluate added value of a 2-step pathway as compared to FibroScan only for detection of high-risk patients

  Number of patients at risk identified by FIB-4 compared to numbers found using LSM by VCTE with FibroScan measurements, and numbers found in combination

  Baseline

Secondary Outcomes (8)

• Build diagnostic model to identify MASH patients in a high-risk population

  Baseline

• Genotypes related to MASH in different European countries: Exploratory

  Baseline

• (Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory

  Baseline

• Prevalence of co-morbidities and associated therapies (especially for CVD) in patients with MASH compared to those without, in high-risk patient populations

  Baseline

• Identify prognostic factors/biomarkers for complications in patients with MASLD and MASH by 5 years follow up

  Throughout follow-up (at 3 and 5 years)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients aged 18-75 years with a current or prior diagnosis of at least one of the following four conditions: type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension. Subjects who meet the inclusion and exclusion criteria will be enrolled at primary care centers in one of the 10 countries.

You may qualify if:

• Newly diagnosed subjects should fulfil criteria for diagnosis of type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, following the study definitions.
• Subjects that are currently being treated for type 2 diabetes mellitus or metabolic syndrome or obesity or arterial hypertension, should have had a prior diagnosis based on study definitions.
• Study definitions:
• Type 2 diabetes mellitus
• At least 2 times a fasting glucose \> 7,0 mmol/L
• Or elevated non-fasting glucose \>11,1 mmol/L 2 hrs after OGTT
• Or HbA1c ≥48 mmol/mol (≥6.5%)
• Or being actively treated for previously diagnosed type 2 diabetes by a health care provider
• Obesity
• Body mass index (BMI) \> 30
• Or waist circumferences Caucasian: male ≥ 94 cm, female ≥ 80 cm South-Asian/Chinese: male ≥90 cm, female ≥80 cm Japanese: male ≥85 cm, female ≥90 cm
• Arterial hypertension
• Systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg
• Or being actively treated for previously diagnosed arterial hypertension by a health care provider
• Metabolic syndrome

You may not qualify if:

• The patient is known with hepatitis B, C or HIV or any other liver condition (like hemochromatosis, sarcoidosis, Wilson's disease etc);
• The patient is known with any other condition that may lead to liver fibrosis or cirrhosis;
• The patient engages in (excessive) alcohol use: \> 3 units/day in males \[30 grams/day\] and \> 2 units/day in females \[20 grams/day\];
• The patient has a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the Investigator, may compromise the patient's safety or ability to be included in this study;
• The patient is an employee or contractor of the facility that is conducting the study or is a family member of the Investigator, sub-Investigator, or any Sponsor personnel;
• The patient is not able to understand the details of the protocol and/or is not able to provide written informed consent;
• The patient is pregnant or breastfeeding.
• The patient underwent bariatric surgery in the last 12 months.

Sponsors & Collaborators

• Julius Clinical: lead
• UMC Utrecht: collaborator
• Echosens: collaborator
• MIMETAS BV: collaborator
• Nordic Bioscience A/S: collaborator
• Elevate BV: collaborator
• Leiden University: collaborator
• Amsterdam University Medical Center: collaborator
• Andaluz Health Service: collaborator
• National Research Council, Institute of Clinical Physiology, Italy: collaborator
• Leiden University Medical Center: collaborator
• Université Libre de Bruxelles: collaborator
• University Hospital, Antwerp: collaborator
• Catholic University of the Sacred Heart: collaborator
• Medical Education Research And Innovation Center S.R.L.: collaborator
• EUROPEAN LIVER PATIENTS ASSOCIATION: collaborator
• Harokopio University: collaborator
• General University Hospital, Prague: collaborator
• Novo Nordisk A/S: collaborator
• Maastricht University: collaborator
• Mercodia Aktiebolag: collaborator
• EXIT071 BV: collaborator
• European Atherosclerosis Society: collaborator
• MetaDeq Limited: collaborator
• Associação para Investigação e Desenvolvimento da Faculdade de Medicina: collaborator
• Institute of Cardiometabolism and Nutrition, France: collaborator
• University Hospital, Saarland: collaborator
• Roche Pharma AG: collaborator
• Inventiva Pharma: collaborator
• Biocellvia: collaborator
• Franciscus Gasthuis & Vlietland (Hospital): collaborator

Study Sites (13)

Hôpital Erasme, Cliniques Universitaires De Bruxelles

Brussels, Vlaams-brabant, B-1070, Belgium

RECRUITING

Antwerp University Hospital

Antwerp, B-2650, Belgium

ACTIVE NOT RECRUITING

4th internal clinic General University Hospital

Prague, Bohemia, 128 08, Czechia

NOT YET RECRUITING

Hôpital de la Pitié Salpêtrière

Paris, Il-de-France, 75013, France

NOT YET RECRUITING

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

NOT YET RECRUITING

Harokopio University of Athens

Athens, 17676, Greece

NOT YET RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)

Rome, Lazio, 00168, Italy

NOT YET RECRUITING

Amsterdam UMC

Amsterdam, South Holland, 1105 AZ, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, 3045 PM, Netherlands

RECRUITING

ULSSM - Unidade Local de Saúde Santa Maria, E.P.E

Lisbon, 1649-028, Portugal

RECRUITING

Sacele Municipal Hospital

Săcele, Brașov County, 505600, Romania

NOT YET RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Related Publications (1)

• de Jong VD, Alings M, Bruha R, Cortez-Pinto H, Dedoussis GV, Doukas M, Francque S, Fournier-Poizat C, Gastaldelli A, Hankemeier T, Holleboom AG, Miele L, Moreno C, Muris JWM, Ratziu V, Romero-Gomez M, Schattenberg JM, Serfaty L, Stefan DC, Tushuizen ME, Verheij J, Willemse J, Franco OH, Grobbee DE, Castro Cabezas M; GRIPonMASH consortium. Global research initiative for patient screening on MASH (GRIPonMASH) protocol: rationale and design of a prospective multicentre study. BMJ Open. 2025 May 30;15(5):e092731. doi: 10.1136/bmjopen-2024-092731.

  PMID: 40447415 DERIVED

Related Links

• GRIPonMASH consortium website

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma, serum, whole blood, DNA), liver tissue

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Diabetes Mellitus, Type 2; Obesity; Metabolic Syndrome; Hypertension

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manuel Castro Cabezas, MD/PhD

  Sint Franciscus Gasthuis

  PRINCIPAL INVESTIGATOR

• Diederick E. Grobbee, MD/PhD/FESC

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Oscar H. Franco, MD/PhD/FESC/FFPH

  UMC Utrecht

  STUDY CHAIR

Central Study Contacts

de Jong

CONTACT

+31628259968; griponmash@juliusclinical.com

Wijkhuis

CONTACT

griponmash@juliusclinical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: December 15, 2022
• Study Start: June 30, 2023
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

ES (1); BE (2); GR (1); NL (2); IT (1); CZ (1); FR (1); PT (1); RO (1); DE (2)