Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH)ENDOCARE-SCREENCT07336563
ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) and Metabolic Syndrome, run by Jarosław Drobnik at 1 site in Poland.
Trial summary
The ENDOCARE-SCREEN study is a single-center, observational, cross-sectional screening study designed to assess the prevalence, phenotypes, and determinants of metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) in adults with components of metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight
- How many people
- 10,000 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jan 2026to 31 Oct 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with potential MAFLD/MASLD syndrome
Who may be able to join
- Age 18-75 years.
- Overweight or obesity (BMI ≥ 25 kg/m²) and/or increased waist circumference and/or at least one metabolic risk factor (e.g., hypertension, dyslipidemia, impaired fasting glucose/prediabetes/type 2 diabetes), as applicable per screening program.
- Participation in the ENDOCARE screening program.
- Ability to provide written informed consent, including consent for processing health-related data
Who cannot join
- Inability to provide informed consent (e.g., significant cognitive impairment, acute severe psychiatric disorder, language barrier).
- Pregnancy or breastfeeding.
- Known advanced liver diseases at baseline (participants may be excluded from primary analyses and/or described separately, per statistical analysis plan).
- Refusal of key screening procedures (e.g., blood sampling or liver ultrasound) preventing determination of liver status.
- Refusal of data processing under General Data Protection Regulation (GDPR) requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
ENDOCARE
Wroclaw, 50-558
Katarzyna Tejza, MSc, 71 726 67 00 ext. +48, k.tejza@endocare.wroclaw.pl
Jarosław Drobnik, Prof. MD, PhD
About this study
Official title: Development of a Database of Metabolic Cases and Prevalence of Metabolic Liver Dysfunction (MAFLD/MASLD) in Individuals With Metabolic Syndrome Characteristics - Screening Study (ENDOCARE - SCREEN)
The ENDOCARE-SCREEN study is a single-center, observational, cross-sectional screening study designed to assess the prevalence, phenotypes, and determinants of metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) in adults with components of metabolic syndrome. Up to 10,000 participants aged ≥18 years with overweight, obesity, or metabolic risk factors will undergo standardized screening including a health questionnaire, anthropometric measurements, blood pressure assessment, laboratory testing, and liver ultrasound. The study aims to generate a comprehensive metabolic-hepatic dataset integrating clinical, laboratory, imaging, and lifestyle data. Collected data will be used to identify metabolic and behavioral risk factors for MASLD, characterize disease phenotypes, and support the development of predictive models. The ENDOCARE-SCREEN study will also serve as a qualification platform for selecting eligible participants for a subsequent interventional randomized controlled trial (ENDOCARE-SUPPORT). The study involves minimal risk procedures routinely used in clinical practice and follows ethical principles outlined in the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) is currently the most common chronic liver disease worldwide and represents the hepatic manifestation of metabolic syndrome. Despite its high prevalence, large-scale standardized screening data integrating metabolic, imaging, and lifestyle factors are limited in Central and Eastern Europe. The ENDOCARE-SCREEN study addresses this gap by implementing a structured screening program in a real-world ambulatory population. The study collects detailed sociodemographic, metabolic, behavioral, and imaging data, allowing for comprehensive phenotyping of liver dysfunction in individuals with metabolic risk. In addition to epidemiological objectives, the study assesses participants' readiness for lifestyle modification and digital health tools, supporting the future implementation of personalized, technology-assisted interventions. Data generated in ENDOCARE-SCREEN will inform clinical decision-making, public health strategies, and the design of subsequent interventional studies.
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Insulin Resistance Syndrome
- Keywords
- MASLD, MAFLD, Metabolic syndrome, Liver steatosis, Screening, Ultrasound, Metabolic health
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome, Obesity, Overweight, Fatty Liver
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 |
|---|---|---|
| Group 1 | Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of MAFLD/MASLD
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Measured: Baseline (single screening visit)
Distribution of hepatic steatosis severity on liver ultrasound
Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).
Measured: Baseline (single screening visit)
Secondary outcomes (7)
Association between MAFLD and metabolic syndrome burden
Relationship between MAFLD status and number of metabolic syndrome components
Measured: Baseline
Association between MAFLD and anthropometric parameters
Relationship between MAFLD and body mass index (BMI) and waist circumference
Measured: Baseline
Association between MAFLD and glycemic status
Relationship between MAFLD and diabetes/prediabetes markers (e.g., fasting glucose/HbA1c as collected)
Measured: Baseline
Association between MAFLD and lipid profile
Relationship between MAFLD and lipid parameters as collected in routine labs
Measured: Baseline
Independent predictors of MAFLD and moderate-to-severe steatosis
Multivariable models (e.g., logistic regression) identifying predictors of MAFLD and moderate-to-severe steatosis
Measured: Baseline
Previously undiagnosed MAFLD/liver disease
Proportion of participants with newly identified MAFLD/liver abnormalities during screening
Measured: Baseline
Eligibility yield for the interventional stage
Proportion of screened participants meeting pre-defined qualification criteria for the second stage (ENDOCARE-SUPPORT)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (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 Disease (MASH) / Nonalcoholic Steatohepatitis (NASH)Studies 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
- Cross-sectional
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jarosław Drobnik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jarosław Drobnik, Endocare, Poland
- Investigators
- Jarosław Drobnik, Prof. MD, PhD, Principal investigator, ENDOCARE Medical Center in Wroclaw, POLAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336563
- Sponsor's protocol ID
- ENDOCARE_23/BNBO/2025
- Acronym
- ENDOCARE-SCREE
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified aggregated results may be shared in scientific publications and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Database of Metabolic Cases and Prevalence of Metabolic Liver Dysfunction (MAFLD/MASLD) in Individuals With Metabolic Syndrome Characteristics - Screening Study (ENDOCARE - SCREEN)
- ClinicalTrials.gov ID
- NCT07336563
- Acronym / sponsor ID
- ENDOCARE-SCREE / ENDOCARE_23/BNBO/2025
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH), Metabolic Syndrome, Obesity & Overweight, Obesity Type 2 Diabetes Mellitus, Insulin Resistance Syndrome
- Keywords
- MASLD, MAFLD, Metabolic syndrome, Liver steatosis, Screening, Ultrasound, Metabolic health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Jarosław DrobnikUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jan 2026 (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 ENDOCARE-SCREEN study is a single-center, observational, cross-sectional screening study designed to assess the prevalence, phenotypes, and determinants of metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) in adults with components of metabolic syndrome. Up to 10,000 participants aged ≥18 years with overweight, obesity, or metabolic risk factors will undergo standardized screening including a health questionnaire, anthropometric measurements, blood pressure assessment, laboratory testing, and liver ultrasound. The study aims to generate a comprehensive metabolic-hepatic dataset integrating clinical, laboratory, imaging, and lifestyle data. Collected data will be used to identify metabolic and behavioral risk factors for MASLD, characterize disease phenotypes, and support the development of predictive models. The ENDOCARE-SCREEN study will also serve as a qualification platform for selecting eligible participants for a subsequent interventional randomized controlled trial (ENDOCARE-SUPPORT). The study involves minimal risk procedures routinely used in clinical practice and follows ethical principles outlined in the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.
Detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD/MAFLD) is currently the most common chronic liver disease worldwide and represents the hepatic manifestation of metabolic syndrome. Despite its high prevalence, large-scale standardized screening data integrating metabolic, imaging, and lifestyle factors are limited in Central and Eastern Europe. The ENDOCARE-SCREEN study addresses this gap by implementing a structured screening program in a real-world ambulatory population. The study collects detailed sociodemographic, metabolic, behavioral, and imaging data, allowing for comprehensive phenotyping of liver dysfunction in individuals with metabolic risk. In addition to epidemiological objectives, the study assesses participants' readiness for lifestyle modification and digital health tools, supporting the future implementation of personalized, technology-assisted interventions. Data generated in ENDOCARE-SCREEN will inform clinical decision-making, public health strategies, and the design of subsequent interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Screening for Metabolic Dysfunction-Associated Steatotic Liver Disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with potential MAFLD/MASLD syndrome
Key inclusion criteria (4 listed)
- Age 18-75 years.
- Overweight or obesity (BMI ≥ 25 kg/m²) and/or increased waist circumference and/or at least one metabolic risk factor (e.g., hypertension, dyslipidemia, impaired fasting glucose/prediabetes/type 2 diabetes), as applicable per screening program.
- Participation in the ENDOCARE screening program.
- Ability to provide written informed consent, including consent for processing health-related data
Key exclusion criteria (5 listed)
- Inability to provide informed consent (e.g., significant cognitive impairment, acute severe psychiatric disorder, language barrier).
- Pregnancy or breastfeeding.
- Known advanced liver diseases at baseline (participants may be excluded from primary analyses and/or described separately, per statistical analysis plan).
- Refusal of key screening procedures (e.g., blood sampling or liver ultrasound) preventing determination of liver status.
- Refusal of data processing under General Data Protection Regulation (GDPR) requirements.
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 MAFLD/MASLD
Time frame: Baseline (single screening visit)
Proportion of participants meeting MAFLD/MASLD criteria according to current definitions
Distribution of hepatic steatosis severity on liver ultrasound
Time frame: Baseline (single screening visit)
Ultrasound steatosis grade (0-3): mild (1), moderate (2), severe (3).
7 secondary outcomes
Association between MAFLD and metabolic syndrome burden
Time frame: Baseline
Association between MAFLD and anthropometric parameters
Time frame: Baseline
Association between MAFLD and glycemic status
Time frame: Baseline
Association between MAFLD and lipid profile
Time frame: Baseline
Independent predictors of MAFLD and moderate-to-severe steatosis
Time frame: Baseline
Previously undiagnosed MAFLD/liver disease
Time frame: Baseline
Eligibility yield for the interventional stage
Time frame: Baseline
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 15 Jan 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified aggregated results may be shared in scientific publications and conference presentations.
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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.
Jarosław Drobnik, Prof. MD, PhD principal investigator
ENDOCARE Medical Center in Wroclaw, POLAND
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 (MASH) / Nonalcoholic Steatohepatitis (NASH) and Metabolic Syndrome, run by Jarosław Drobnik at 1 site in Poland.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Jan 2026. 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 Poland. 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 Katarzyna Tejza, MSc (71 726 67 00 ext. +48, k.tejza@endocare.wroclaw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of MAFLD/MASLD (time frame: Baseline (single screening visit)). The study lists 2 primary outcomes in all. 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 15 Jan 2026.