Development of a Non-invasive Screening Tool to Predict NAFLD

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

Detailed Description
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Fatty liver disease is a common condition (25% of the population) which can lead to liver inflammation, liver scarring and even liver cancer. Clinical trials are often performed in healthy volunteers, who may have underlying fatty liver without knowledge of it. In clinical trials fatty liver can both mean volunteers have abnormal liver tests, preventing them joining the trial, as well as more likely to have a possible liver drug reaction, causing volunteers to withdraw from a clinical trial of a new drug. The principal objective of the study is to develop a clinical scoring tool that can accurately predict fatty liver disease in study volunteers, without the need for invasive tests (such as a tissue biopsy). We aim to recruit initially 500 volunteers to this study, both healthy volunteers and patients with known NAFLD. Volunteers will attend the unit to undergo all assessments on one day. Once consent is given with a study research physician, bloods will be taken and body measurements made (including BMI, weight, waist circumference). A full medical history and physical examination will then be performed by the research physician. Bioimpedance body composition analysis will then be performed on an ACUNIQ device. Finally ultrasound of the liver and fibroscan will be performed. Once all assessments are complete the study volunteer will be discharged from the unit. Once all results are finalised, analysis will be performed on all the data to create a clinical score to predict the presence of NAFLD, both with statistical and machine learning methods.

Official Title
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Development of a Non-invasive Screening Tool to Predict NAFLD in Volunteers on Clinical Trials Utilising Machine-learning and Bioimpedance Vector Analysis

Conditions
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Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. For PART B only: 1. With a known history of NAFLD as evidenced either of: GP diagnosis on HCF Documented Fibroscan or liver US demonstrating NAFLD Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 NAFLD on liver USS. | Study duration (1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal LFT Range in NAFLD patients | The normal range of LFT's in patients with known NAFLD | Study duration (1 year) |