Clinical trial NCT04873258: Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease
Official title: Development of a Non-invasive Screening Tool to Predict Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Volunteers on Clinical Trials Utilising Machine-learning and Bioimpedance Vector Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Fatty Liver
MASLD
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Obesity and Obesity-related Medical Conditions
Keywords: Fatty liver
MASLD
Lead sponsor: Richmond Pharmacology Limited
Sponsor class: INDUSTRY
Collaborators: name: Richmond Pharmacology Limited
First posted: 2021-05-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male or female volunteers for other clinical trials taking place at the study unit.

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

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 2000 volunteers to this study, both healthy volunteers and patients with known MASLD.

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 MASLD, both with statistical and machine learning methods.

Eligibility 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

Primary outcomes:
measure: Establishment of Classification Tool for Use in Clinical Trials
timeFrame: Study duration (1 year)
Secondary outcomes:
measure: Normal LFT Range in NAFLD patients
timeFrame: Study duration (1 year)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge
Study officials:
affiliation: Richmond Pharmacology Limited
name: Jorg Taubel, MD
role: PRINCIPAL_INVESTIGATOR
References: