Clinical trial NCT04666402: Integrated Diagnostics for Early Diagnosis of Liver Disease
Official title: Integrated Diagnostics for Early Diagnosis of Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Alcoholic Liver Disease
Liver Fibroses
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Manchester
name: University of Nottingham
name: Innovate UK
First posted: 2020-12-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess

Brief summary: This is an observational study that will explore the hypothesis that by combining data from patients with liver disease with novel blood biomarkers, single nucleotide polymorphism (SNP) analysis and faecal microbiome analysis. The Investigators will improve diagnosis of liver fibrosis compared to the current available diagnostic tools.

Detailed description: Liver disease is a silent epidemic. Four in ten people in the North West are likely to have evidence of liver disease. A small but significant proportion of these patients develop scarring, leading to end-stage cirrhosis. All too frequently this is detected in very advanced stages, where treatment cannot reverse the condition. It is one of the UK's largest health challenges. At present clinicians use a wide range of single tests that individually struggle to identify disease and high-risk patients early.

The Investigators are implementing a new pathway for the assessment of patients with abnormal liver blood tests or high risk for liver disease. This novel pathway will allow assessment of patients in Community Liver Assessment Clinics (CLAC) with the expectation that only 20% of patients assessed would need to be seen in secondary care for further assessment. The investigators expect, to be assessing, 750 patients per year in this pathway. This pathway will bring together a large group of patients with liver disease. As part of the clinical assessment the investigators will be undertaking investigations to diagnose disease and assess extent. This will generate significant information, that the investigators currently use in isolation to make the aforementioned assessments. In this study, the investigators would like to bring together all this data into a curated database. To this end, the investigators would offer all patients who attend the CLAC for clinical need to enrol into the study. This would generate a database to combine all data, alongside some other, non-invasive tests, done alongside routine clinical tests.

This project will address this lack of answers by teaming up with innovative companies to make software that joins together a wide range of different tests to make an algorithm to detect disease earlier.

Eligibility criteria: Inclusion Criteria:

* All patients referred to Community Liver Assessment Clinic.
* Male or female \> 18 years of age.
* Females will be non-pregnant and non-lactating.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
* Isolated bilirubinaemia.
* Known pre-existing liver disease.
* Acutely unwell.
* Suspected malignancy.

Primary outcomes:
measure: Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
timeFrame: At study completion; within 3 years
Secondary outcomes:
measure: To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
timeFrame: At study completion; Within 3 years
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: Manchester University NHS Foundation Trust/Manchester University
name: Varinder Athwal
role: PRINCIPAL_INVESTIGATOR
References: