RecruitingNCT02037867

Nottingham Community Liver Biomarkers Cohort

The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers


Sponsor

University of Nottingham

Enrollment

2,000 participants

Start Date

May 1, 2013

Study Type

OBSERVATIONAL

Conditions

Summary

Deaths due to advanced liver scarring (liver cirrhosis) continue to increase, and liver disease is now the 3rd leading cause of premature death in the United Kingdom. The majority of liver disease is lifestyle related (alcohol, obesity and associated type 2 diabetes, injecting drug use) and therefore reversible if caught at a precirrhosis stage. However, current liver function blood tests are poor inadequate, and subsequently a large burden of liver disease is currently missed. A variety of noninvasive liver biomarkers (blood and imaging tests) have been developed which identify liver disease accurately at earlier stages of scarring. The identification of liver disease in the community, where previous studies have discovered a large burden of previously unidentified but significant liver disease, is therefore a feasible place to develop new liver disease investigation pathways using these noninvasive markers. In collaboration with the Department of Health, Nottingham University Hospitals have commenced a pilot community liver disease pathway in two General Practices in Nottingham in February 2012. Patients with liver risk factors (hazardous alcohol use, obesity or type 2 diabetes)are invited to take part in the pathway. Patients undergo a simple blood test (AST:ALT ratio and BARD score), with a high test result requiring referral for a liver stiffness scan (Fibroscan)which is performed in the community setting. High threshold scan values are reviewed by a consultant liver specialist in a community liver clinic. Preliminary findings show that the pathway accurately identifies patients with early liver scarring and previously unidentified significant liver disease. The participating General Practitioners have also noted a striking number of patients finally engaging in important lifestyle changes following pathway implementation. A second phase of the pilot pathway, in 2 Inner City General Practices with a total practice population of c.14,000 patients commenced in June 2013. We have subsequently designed this cohort study, where pilot participants will be consented for follow up over a long period. We will assess future liver-related and cardiovascular events (including death), and perform qualitative patient interviews to assess the reasons for and persistence of lifestyle changes after liver disease investigation. We hypothesize that stratification of liver disease in the community will unearth a significant amount of previously undetected but significant chronic liver disease. Moreover, we will evaluate whether stratification of liver disease using these tests predicts future liver and cardiovascular disease and death, and whether stratification has an impact on patient's future lifestyle choices.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is building a community-based research group in Nottingham, UK, that collects blood samples and health information from people at risk of liver disease (including those who drink alcohol heavily or have obesity) to help identify early markers of liver damage and improve future diagnosis. **You may be eligible if...** - You live in the Nottingham area and are willing to participate in long-term health monitoring - You may be at risk of liver disease (for example, due to heavy alcohol use, obesity, type 2 diabetes, or a family history of liver disease) - You are willing to provide blood samples and answer health questionnaires at regular intervals - You are at least 18 years old **You may NOT be eligible if...** - You already have an established diagnosis of advanced liver disease (cirrhosis) - You are pregnant - You are unable to attend the study clinic in Nottingham - You are unwilling to consent to sample collection and long-term follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFibrosis Biomarkers

Liver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis


Locations(1)

NIHR Nottingham Digestive Diseases Biomedical Research Unit

Nottingham, Notts, United Kingdom

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NCT02037867


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