At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Blood tests for Single Nucleotide Polymorphisms (other), Faecal microbiome analysis (diagnostic test), Serum for diagnostic biomarkers (diagnostic test)
- How long the study runs
- Study runs about 77 months (dates as stated)
- About the drug or intervention
- Blood tests for Single Nucleotide Polymorphisms — other: This extra test would be performed on participants assessed in the specialist liver clinic. · Faecal microbiome analysis — diagnostic test: 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. · Serum for diagnostic biomarkers — diagnostic test: Blood samples will be taken alongside blood taken for clinical assessment.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,200
- Started
- 2020-10-21
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for non-alcoholic fatty liver disease
- • Clinical study - 1,200 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-alcoholic fatty liver disease
Where?
- • Manchester - Manchester University NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓All patients referred to Community Liver Assessment Clinic.
- ✓Male or female \> 18 years of age.
- ✓Females will be non-pregnant and non-lactating.
Who cannot take part
- ✗Age \< 18 years.
- ✗Pregnancy/breast-feeding. Women of childbearing potential (not \>2 years post- menopausal and/or not surgically...
- ✗Isolated bilirubinaemia.
- ✗Known pre-existing liver disease.
- ✗Acutely unwell.
See the full criteria
Where Is This Study? (1 UK site)
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
How to Get in Touch
Varinder Athwal
Sponsor contactCONTACT
