Global Research Initiative for Patients Screening on MASH (GRIPonMASH)

July 30, 2024 updated by: Julius Clinical

Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

GRIPonMASH is an observational study in which 10.000 high risk patients (type 2 diabetes mellitus, metabolic syndrome, obesity or arterial hypertension) in 10 different European countries will be screened for the presence of MASLD, liver fibrosis and (at-rsik) MASH using at least two non-invasive tests (FIB-4 and FibroScan). Additional published and exploratory non-invasive test will also be investigated. Blood samples and liver biopsy material will be collected. Genomic, proteomic, metabolomic, lipidomic and fluxomic studies will be applied to gain a better understanding of the pathophysiology of MASLD and to identify (bio)markers that will help to detect patients at-risk. The predictive value of FIB-4 in relation to FibroScan results and liver biopsy will be analysed. Long-term follow-up of 5 years in all participants will provide insight into the natural history of the disease.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium, B-2650
        • Active, not recruiting
        • Antwerp University Hospital
    • Vlaams-brabant
      • Brussels, Vlaams-brabant, Belgium, B-1070
        • Recruiting
        • Hôpital Erasme, Cliniques Universitaires De Bruxelles
  • Czechia
    • Bohemia
      • Prague, Bohemia, Czechia, 128 08
        • Not yet recruiting
        • 4th internal clinic General University Hospital
  • France
    • Il-de-France
      • Paris, Il-de-France, France, 75013
        • Not yet recruiting
        • Hôpital de la Pitié Salpêtrière
  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitatsmedizin Mainz
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Not yet recruiting
        • Universitatsklinikum des Saarlandes
  • Greece
      • Athens, Greece, 17676
        • Not yet recruiting
        • Harokopio University of Athens
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
        • Recruiting
        • Franciscus Gasthuis & Vlietland
    • Zuid-holland
      • Amsterdam, Zuid-holland, Netherlands, 1105 AZ
        • Recruiting
        • Amsterdam UMC
  • Portugal
      • Lisbon, Portugal, 1649-028
        • Recruiting
        • ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
  • Romania
    • Brasov
      • Sacele, Brasov, Romania, 505600
        • Not yet recruiting
        • Sacele Municipal Hospital
  • Spain
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

- Central obesity defined as waist circumference (see above), if BMI is >30 kg/m2, central obesity can be assumed and waist circumference does not need to be measured

AND any two of the following:

  • Raised triglycerides: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality
  • Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L) in males, < 50 mg/dL (1.29 mmol/L) in females, or specific treatment for this lipid abnormality
  • Raised blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension
  • Raised fasting plasma glucose (FPG): FGP ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (if above >5.6 mmol/L or 100 mg/dL, an oral glucose tolerance test is strongly recommended, but is not necessary to define presence of the syndrome)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk
Time Frame: Baseline
Steatosis grade deduced from controlled attenuation parameter (CAP) measurement with Fibroscan
Baseline
Prevalence of liver fibrosis estimated by FibroScan LSM in patients at risk
Time Frame: Baseline
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
Time Frame: Baseline
At-risk MASH deduced from FAST score
Baseline
*Subset of patients: prevalence of MASH in patients at risk
Time Frame: 16 or 30 weeks
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
Time Frame: Baseline (1-3) to 16/30 weeks for biopsy-confirmed MASH (4)
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
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Build diagnostic model to identify MASH patients in a high-risk population
Time Frame: Baseline
Possible model parameters are all baseline clinical characteristics reported in the eCRF
Baseline
Genotypes related to MASH in different European countries: Exploratory
Time Frame: Baseline
Genomic (GWAS) and proteomic analysis on collected blood samples
Baseline
(Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory
Time Frame: Baseline
Mass-spectrometry (MS) based metabolomic and lipidomic analyses on collected blood and samples, both targeted and untargeted approaches.
Baseline
Prevalence of co-morbidities and associated therapies (especially for CVD) in patients with MASH compared to those without, in high-risk patient populations
Time Frame: Baseline
Prevalence of comorbidities, medication use, medical history
Baseline
Identify prognostic factors/biomarkers for complications in patients with MASLD and MASH by 5 years follow up
Time Frame: Throughout follow-up (at 3 and 5 years)
Disease progression and liver-related and non-liver related complications
Throughout follow-up (at 3 and 5 years)
Patient Reported Outcomes: Dietary habits and lifestyle
Time Frame: Baseline + throughout follow-up (at 3 and 5 years)
14 item Mediterranean Diet Score; lifestyle surveys
Baseline + throughout follow-up (at 3 and 5 years)
*Subset of patients: Second FibroScan examination
Time Frame: 14 weeks
CAP and LSM by VCTE at 2nd FibroScan examination
14 weeks
Longitudinal changes in liver assessments
Time Frame: Baseline, 14 weeks + throughout follow-up (at 3 and 5 years)
Repeated CAP, LSM by VCTE and FAST measurements over time
Baseline, 14 weeks + throughout follow-up (at 3 and 5 years)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimation of the additional costs of implementing a patient care pathway as proposed in this study in clinical practice: Pilot
Time Frame: Baseline + throughout follow-up (at 3 and 5 years)
Estimation of the actual costs of implementing the patient care pathway
Baseline + throughout follow-up (at 3 and 5 years)
Assess if implementation of the patient care pathway as proposed in this study increases awareness and knowledge of NAFLD and NASH management among participating physicians and clinicians
Time Frame: Baseline + throughout follow-up (at 3 and 5 years)
Questionnaire send out to participating physicians and clinicians to assess awareness and knowledge of NAFLD and NASH management (questionairre to be developed within this study)
Baseline + throughout follow-up (at 3 and 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Julius Clinical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Novo Nordisk A/S
Roche Pharma AG
UMC Utrecht
Catholic University of the Sacred Heart
Leiden University
University Hospital, Antwerp
Andaluz Health Service
Leiden University Medical Center
Inventiva Pharma
University Hospital, Saarland
Maastricht University
Harokopio University
General University Hospital, Prague
Université Libre de Bruxelles
Echosens
Nordic Bioscience A/S
National Research Council, Institute of Clinical Physiology, Italy
Institute of Cardiometabolism and Nutrition, France
Amsterdam University Medical Center
Franciscus Gasthuis & Vlietland (Hospital)
European Atherosclerosis Society
MIMETAS BV
Elevate BV
Medical Education Research And Innovation Center S.R.L.
EUROPEAN LIVER PATIENTS ASSOCIATION
Mercodia Aktiebolag
EXIT071 BV
MetaDeq Limited
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Biocellvia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manuel Castro Cabezas, MD/PhD, Sint Franciscus Gasthuis
  • Principal Investigator: Diederick E. Grobbee, MD/PhD/FESC, UMC Utrecht
  • Study Chair: Oscar H. Franco, MD/PhD/FESC/FFPH, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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