NCT07336563Not yet recruiting
ENDOCARE-SCREEN: Metabolic Liver Dysfunction Screening Study
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)
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 2 Jan 2026
- Start date
- 5 Jan 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Jarosław Drobnik
- NCT number
- NCT07336563
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 5 Jan 2026 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to provide informed consent (e.g., significant cognitive impairment, acute severe psychiatric disorder, language barrier).
- Known advanced liver diseases at baseline (participants may be excluded from primary analyses and/or described separately, per statistical analysis plan).
Other
- Pregnancy or breastfeeding.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ENDOCARE Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.