Nottingham Community Liver Biomarkers Cohort
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|ClinicalTrials.gov Identifier: NCT02037867|
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : February 8, 2019
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.
|Condition or disease||Intervention/treatment|
|Chronic Liver Disease Alcohol Use Disorder Type 2 Diabetes Persistently Elevated ALT Obesity||Device: Fibrosis Biomarkers|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2000 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2033|
|Estimated Study Completion Date :||May 2033|
Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers:
Device: Fibrosis 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
Other Name: AST:ALT ratio, APRI, BARD score, ELF Score, FIB4, NAFLD Fibrosis Score,Transient Elastography
- Liver and cardiovascular-related mortality [ Time Frame: 20 years ]Death recorded as resulting from cardiovascular or liver-related causes
- Liver Cirrhosis [ Time Frame: 20 years ]Incidence of compensated and decompensated cirrhosis diagnosis during the study period.
- Cardiovascular Disease [ Time Frame: 20 years ]Incidence of cardiovascular disease events(defined as symptomatic coronary or cerebrovascular disease)during the study period.
- All-cause mortality [ Time Frame: 20 years ]Recording of any death during the study period
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037867
|NIHR Nottingham Digestive Diseases Biomedical Research Unit||Recruiting|
|Nottingham, Notts, United Kingdom, NG7 2UH|
|Contact: Neil Guha, MRCP, PhD 01159249924 ext 70609 firstname.lastname@example.org|
|Contact: Rebecca Harris, BMedSci, BMBS 01159249924 ext 70616 email@example.com|
|Principal Investigator: Neil Guha, MRCP, PhD|
|Sub-Investigator: David J Harman, BMedSci, BMBS, MRCP|
|Sub-Investigator: Guruprasad P Aithal, FRCP, PhD|
|Sub-Investigator: Stephen D Ryder, MRCP, PhD|
|Sub-Investigator: Martin W James, MRCP, PhD|
|Sub-Investigator: Emilie A Wilkes, MRCP, PhD|
|Sub-Investigator: Rebecca Harris, BMedSci, BMBS, MRCP|
|Sub-Investigator: Timothy R Card, MRCP, PhD|
|Sub-Investigator: Toby E Delahooke, MRCP, MD|
|Principal Investigator:||Neil Guha, MRCP, PhD||University of Nottingham|