LiveWell - Liver disease screening study
Research type
Research Study
Full title
The Development of a Combined Multi-Modal Non-Invasive Biomarker Screening Approach for High-Risk Undiagnosed Liver Disease
IRAS ID
336013
Contact name
Patrick Short
Contact email
Sponsor organisation
Sano Genetics
Duration of Study in the UK
1 years, 5 months, 3 days
Research summary
Long term liver disease is an increasing problem with as many as 20% of the adult population affected by the most common cause (non-alcoholic fatty liver disease / metabolic dysfunction associated liver disease – METALD). This condition causes progressive liver damage but is generally silent. The patient has no symptoms until advanced and untreatable disease is present. This means poor outcomes for patients who have missed opportunities for treatment. In addition, the metabolic problem is associated with increased risk of diabetes, heart disease and 13 major cancer types. Diagnosing high risk patients early therefore provides significant opportunities for prevention.
No population-wide screening programmes exist for long term liver disease. Developing such programmes is difficult because multiple liver diagnoses exist, and there is a broad range of risk. It is not sufficient simply to screen for the presence or absence of disease. In order to improve population health, it is important to develop risk-stratification programmes rather than screening, and to develop cost-effective solutions which combine the results of several types of tests a single screening intervention.
The purpose of this project therefore is to evaluate a combination of validated risk-stratification approaches and combine these into single solution for population level testing. The project combines longitudinal blood test integration (the hepatoSIGHT platform) with genetic testing for markers associated with liver disease and ultrasound-based liver assessment (for fat and scarring).
We will target individuals (age 25-35 and 45-55) at risk of progressive liver disease from their longitudinal pre-existing blood tests; an approach which we have previously shown to be more powerful than looking at results at a single point in time. Higher risk patients will be invited for scanning and genetic testing. By looking at outcomes for these patients we expect to show that this combination would be effective for population level risk stratification.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0059
Date of REC Opinion
12 Apr 2024
REC opinion
Further Information Favourable Opinion