MASHGRIPonMASHNCT05651724
Global Research Initiative for Patients Screening on MASH
An observational study of MASH and MASLD, run by Julius Clinical at 13 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MASH, MASLD, MASH With Fibrosis
- How many people
- 10,000 participants
- Where
- 13 sitesin 10 countries
- Study dates
- 30 Jun 2023to 31 Mar 2031
- How long will I take part?
- 5 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 21Show fewer
- 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)
Who cannot join
- 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.
Trial locations and contacts
13 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
Wijkhuis contact
13 sites in 10 countries
Belgium2 sites, 1 recruiting
- Active, not recruiting
Antwerp University Hospital
Antwerp, B-2650
- Recruiting
Hôpital Erasme, Cliniques Universitaires De Bruxelles
Brussels, Vlaams-brabant, B-1070
Germany2 sites, 2 recruiting
- Not yet recruiting
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
- Recruiting
Universitätsmedizin Mainz
Mainz, Rhineland-Palatinate, 55131
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, South Holland, 1105 AZ
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045 PM
Czechia1 site, 1 recruiting
- Not yet recruiting
4th internal clinic General University Hospital
Prague, Bohemia, 128 08
France1 site, 1 recruiting
- Not yet recruiting
Hôpital de la Pitié Salpêtrière
Paris, Il-de-France, 75013
Greece1 site, 1 recruiting
- Not yet recruiting
Harokopio University of Athens
Athens, 17676
Italy1 site, 1 recruiting
- Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), Università Cattolica del Sacro Cuore (UCSC)
Rome, Lazio, 00168
Portugal1 site, 1 recruiting
- Recruiting
ULSSM - Unidade Local de Saúde Santa Maria, E.P.E
Lisbon, 1649-028
Romania1 site, 1 recruiting
- Not yet recruiting
Sacele Municipal Hospital
Săcele, Brașov County, 505600
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
About this study
Official title: 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.
Read the 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.
- Conditions
- MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver, Steatosis of Liver, Type 2 Diabetes
- Keywords
- MASLD, MASH, Screening, Patient care pathway
- Medical subject headings
- Liver Cirrhosis, Fatty Liver, Diabetes Mellitus, Type 2, Obesity, Metabolic Syndrome, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline
Prevalence of at-risk MASH estimated by FAST score in patients at risk
At-risk MASH deduced from FAST score
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Secondary outcomes (8)
Build diagnostic model to identify MASH patients in a high-risk population
Possible model parameters are all baseline clinical characteristics reported in the eCRF
Measured: Baseline
Genotypes related to MASH in different European countries: Exploratory
Genomic (GWAS) and proteomic analysis on collected blood samples
Measured: Baseline
(Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory
Mass-spectrometry (MS) based metabolomic and lipidomic analyses on collected blood and samples, both targeted and untargeted approaches.
Measured: Baseline
Prevalence of co-morbidities and associated therapies (especially for CVD) in patients with MASH compared to those without, in high-risk patient populations
Prevalence of comorbidities, medication use, medical history
Measured: Baseline
Identify prognostic factors/biomarkers for complications in patients with MASLD and MASH by 5 years follow up
Disease progression and liver-related and non-liver related complications
Measured: Throughout follow-up (at 3 and 5 years)
Patient Reported Outcomes: Dietary habits and lifestyle
14 item Mediterranean Diet Score; lifestyle surveys
Measured: Baseline + throughout follow-up (at 3 and 5 years)
*Subset of patients: Second FibroScan examination
CAP and LSM by VCTE at 2nd FibroScan examination
Measured: 14 weeks
Longitudinal changes in liver assessments
Repeated CAP, LSM by VCTE and FAST measurements over time
Measured: Baseline, 14 weeks + throughout follow-up (at 3 and 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start30 Jun 2023
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MASHStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Julius Clinical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, Echosens, MIMETAS BV, Nordic Bioscience A/S, Elevate BV, Leiden University, Amsterdam University Medical Center, Andaluz Health Service, National Research Council, Institute of Clinical Physiology, Italy, Leiden University Medical Center, Université Libre de Bruxelles, University Hospital, Antwerp, Catholic University of the Sacred Heart, Medical Education Research And Innovation Center S.R.L., European Liver Patients' Association, Harokopio University, General University Hospital, Prague, Novo Nordisk A/S, Maastricht University, Mercodia Aktiebolag, EXIT071 BV, European Atherosclerosis Society, MetaDeq Limited, Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Institute of Cardiometabolism and Nutrition, France, University Hospital, Saarland, Roche Pharma AG, Inventiva Pharma, Biocellvia, Franciscus Gasthuis & Vlietland (Hospital)
- Responsible party
- Sponsor
- Investigators
- Manuel Castro Cabezas, MD/PhD, Principal investigator, Sint Franciscus GasthuisDiederick E. Grobbee, MD/PhD/FESC, Principal investigator, UMC UtrechtOscar H. Franco, MD/PhD/FESC/FFPH, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651724
- Sponsor's protocol ID
- GOM
- Acronym
- GRIPonMASH
- Status last verified
- Jul 2024
- First submitted
- 18 Oct 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40447415
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Research Initiative for Patients Screening on MASH - Implementation of an International Transmural Patient Care Pathway
- ClinicalTrials.gov ID
- NCT05651724
- Acronym / sponsor ID
- GRIPonMASH / GOM
- Conditions
- MASH, MASLD, MASH With Fibrosis, Fibrosis, Liver, Steatosis of Liver, Type 2 Diabetes
- Keywords
- MASLD, MASH, Screening, Patient care pathway
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Julius ClinicalIndustry (pharma, biotech, devices)
- Collaborators
- UMC Utrecht, Echosens, MIMETAS BV, Nordic Bioscience A/S, Elevate BV, Leiden University, Amsterdam University Medical Center, Andaluz Health Service, National Research Council, Institute of Clinical Physiology, Italy, Leiden University Medical Center, Université Libre de Bruxelles, University Hospital, Antwerp, Catholic University of the Sacred Heart, Medical Education Research And Innovation Center S.R.L., European Liver Patients' Association, Harokopio University, General University Hospital, Prague, Novo Nordisk A/S, Maastricht University, Mercodia Aktiebolag, EXIT071 BV, European Atherosclerosis Society, MetaDeq Limited, Associação para Investigação e Desenvolvimento da Faculdade de Medicina, Institute of Cardiometabolism and Nutrition, France, University Hospital, Saarland, Roche Pharma AG, Inventiva Pharma, Biocellvia, Franciscus Gasthuis & Vlietland (Hospital)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 15 Dec 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (21 listed)
- 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.
- 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
Key exclusion criteria (8 listed)
- 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;
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
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
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
Prevalence of at-risk MASH estimated by FAST score in patients at risk
Time frame: Baseline
At-risk MASH deduced from FAST score
*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
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
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
8 secondary outcomes
Build diagnostic model to identify MASH patients in a high-risk population
Time frame: Baseline
Genotypes related to MASH in different European countries: Exploratory
Time frame: Baseline
(Non-invasive) metabolite biomarkers identifying MASH in patients at risk: Exploratory
Time frame: 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
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)
Patient Reported Outcomes: Dietary habits and lifestyle
Time frame: Baseline + throughout follow-up (at 3 and 5 years)
*Subset of patients: Second FibroScan examination
Time frame: 14 weeks
Longitudinal changes in liver assessments
Time frame: Baseline, 14 weeks + throughout follow-up (at 3 and 5 years)
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 1 Aug 2024.
- Derived from this study: PubMed 40447415de 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.
- GRIPonMASH consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Exercise for an Aging Liver (EXALIVER)
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A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
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A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Not yet recruitingPhase 2
To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis
Metabolic Dysfunction-associated Steatohepatitis (MASH)
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.
Wijkhuis contact
Manuel Castro Cabezas, MD/PhD principal investigator
Sint Franciscus Gasthuis
Diederick E. Grobbee, MD/PhD/FESC principal investigator
UMC Utrecht
Oscar H. Franco, MD/PhD/FESC/FFPH study chair
UMC Utrecht
13 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASH and MASLD, run by Julius Clinical at 13 sites in 10 countries.
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 21 inclusion and 8 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Belgium, Germany, Netherlands, Czechia, France and 5 more countries. 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 de Jong (+31628259968, griponmash@juliusclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of liver steatosis and MASLD estimated by FibroScan CAP in patients at risk (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651724, which also lists 1 linked publication.
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 1 Aug 2024.