An observational study in Non-Alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis and Alcoholic Liver Disease, sponsored by Manchester University NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Manchester University NHS Foundation Trust · Observational
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.
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
This test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
Blood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.
Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis.
Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.
Time frame: At study completion; within 3 years
To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis
Through combining the data from basic clinical bloods such as LFTs, non-invasive scoring systems such as FIB-4 and NAFLD fibrosis scores along with the novel biomarkers, we will use this data through AI to develop algorithms that will aid the diagnosis of advanced fibrosis/cirrhosis.
Time frame: At study completion; Within 3 years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2020 (actual). Primary completion is estimated for Mar 2027, 77 months after the start.
Of 159 non-industry observational studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 125. This study's planned 77 months is above that.
Counting every sponsor, half of 170 studies reached it within 49 months; a quarter within 25 and three quarters within 124.
How these figures are worked out, and which studies are left out of them.
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