Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRichmond Research Institute

About this trial

A generic screening study to establish structural and/or functional baselines of specific organs.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.

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.

An understanding, ability and willingness to fully comply with project procedures and restrictions.

GP diagnosis on HCF

Disqualifiers

Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)

Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)

Alcohol consumption >30 units per week

An Implanted cardiac devices

Trial population

Adult male or female volunteers for other clinical trials taking place at the study unit.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bioimpedence Vector Analysis

    Diagnostic test

    Bioimpedence vector analysis

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Patients with MASLD1 intervention
Group B: Healthy volunteers1 intervention

Trial outcomes

Primary outcomes

1

Establishment of Classification Tool for Use in Clinical Trials

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.

Time frame
Study duration (1 year)

Secondary outcomes

1

Normal LFT Range in NAFLD patients

The normal range of LFT's in patients with known NAFLD

Time frame
Study duration (1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Richmond Research Institute

Lead sponsor

Richmond Pharmacology Limited

Collaborator