Clinical trial
Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
Recruiting now · Not applicable · 1 countries · Registry ID NCT04873258
Recruiting nowNot applicableObservational
What this study is about
A generic screening study to establish structural and/or functional baselines of specific organs.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 80 Years
SexAll
Healthy volunteersAccepted
ConditionHealthy, Fatty Liver, MASLD, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Obesity and Obesity-related Medical Conditions
Full registry criteria
Inclusion Criteria: 1. Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent. 2. Willingness and ability to provide written, personally signed, and dated informed consent, in accordance with the latest ICH Good Clinical Practice (GCP) Guidelines and applicable regulations. 3. An understanding, ability and willingness to fully comply with project procedures and restrictions. For PART B only: 1\. With a known history of MASLD as evidenced either of: 1. GP diagnosis on HCF 2. Documented Fibroscan or liver US demonstrating MASLD Exclusion Criteria: 1. Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other) 2. Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease) 3. Alcohol consumption \>30 units per week 4. An Implanted cardiac devices
Treatments and study arms
Bioimpedence Vector Analysis
Diagnostic Test
Bioimpedence vector analysis
Primary outcomes
Establishment of Classification Tool for Use in Clinical TrialsStudy duration (1 year)
The success of the final classification tool (as measured by area under the receiver operator curve (AUROC). The initial measure to generate the dataset will be the presence or absence of MASLD on liver USS.