Development of a Non-invasive Screening Tool to Predict NAFLD
Study Details
Study Description
Brief Summary
A generic screening study to establish structural and/or functional baselines of specific organs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Establishment of Classification Tool for Use in Clinical Trials [Study 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 NAFLD on liver USS.
Secondary Outcome Measures
- Normal LFT Range in NAFLD patients [Study duration (1 year)]
The normal range of LFT's in patients with known NAFLD
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female volunteers aged ≥18 to ≤80 years at the date of signing the informed consent.
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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.
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An understanding, ability and willingness to fully comply with project procedures and restrictions.
For PART B only:
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With a known history of NAFLD as evidenced either of:
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GP diagnosis on HCF
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Documented Fibroscan or liver US demonstrating NAFLD
Exclusion Criteria:
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Known alcoholic liver disease, history of cirrhosis of any other cause (metabolic, viral hepatitis or other)
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Any other significant previous liver pathology (liver malignancy, portal hypertension, infiltrative liver disease)
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Alcohol consumption >30 units per week
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An Implanted cardiac devices
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge | London | United Kingdom | SE1 1YR |
Sponsors and Collaborators
- Richmond Research Institute
- Richmond Pharmacology Limited
Investigators
- Principal Investigator: Jorg Taubel, MD, Richmond Pharmacology Limited
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C19030