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The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
Sponsor study identifier
Secondary identifiers
OTHER · Research Ethics Committee (East Midlands - Leicester)
observational
2,000
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 14, 2014
Actual (reported)January 16, 2014
Actual (reported)May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Liver and cardiovascular-related mortality
Death recorded as resulting from cardiovascular or liver-related causes
20 years
Liver Cirrhosis
20 years
Cardiovascular Disease
20 years
All-cause mortality
20 years
Patients identified with one of the below chronic liver disease risk factors and undergoing community liver disease stratification using fibrosis biomarkers: * Hazardous alcohol use (\>14 units per week in females, \>21 units per week in males, alcohol AUDIT score \>=8 or read code relevant to alcohol abuse on GP system) * Type 2 Diabetes * Obesity * Persistently raised serum ALT level, negative liver serology, and absence of above 2 risk factors
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
A Primary Care database search (Systmone, TPP)will be performed to identify patients eligible for study (see inclusion criteria) in the discrete patient populations.
NIHR Nottingham Digestive Diseases Biomedical Research Unit
Nottingham, Notts, NG7 2UH, United Kingdom
Bradley CR, Cox EF, Palaniyappan N, Aithal GP, Francis ST, Guha IN. Variability of noninvasive MRI and biological markers in compensated cirrhosis: insights for assessing disease progression. Eur Radiol Exp. 2022 Oct 24;6(1):52. doi: 10.1186/s41747-022-00303-y.
Tanajewski L, Harris R, Harman DJ, Aithal GP, Card TR, Gkountouras G, Berdunov V, Guha IN, Elliott RA. Economic evaluation of a community-based diagnostic pathway to stratify adults for non-alcoholic fatty liver disease: a Markov model informed by a feasibility study. BMJ Open. 2017 Jul 5;7(6):e015659. doi: 10.1136/bmjopen-2016-015659.
Serum, whole blood and urine samples stored a -80 degrees Celsius.
Neil Guha, MRCP, PhD
University of Nottingham
First Submitted
January 14, 2014
First Posted
January 16, 2014
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2033
EstimatedContact the study team to confirm eligibility.
Harman DJ, Ryder SD, James MW, Jelpke M, Ottey DS, Wilkes EA, Card TR, Aithal GP, Guha IN. Direct targeting of risk factors significantly increases the detection of liver cirrhosis in primary care: a cross-sectional diagnostic study utilising transient elastography. BMJ Open. 2015 May 3;5(4):e007516. doi: 10.1136/bmjopen-2014-007516.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 8, 2019
Record last verified: 2019-02
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