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Nottingham Community Liver Biomarkers Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02037867
Recruitment Status : Recruiting
First Posted : January 16, 2014
Last Update Posted : February 8, 2019
Information provided by (Responsible Party):
University of Nottingham

Brief 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.

Condition or disease Intervention/treatment
Chronic Liver Disease Alcohol Use Disorder Type 2 Diabetes Persistently Elevated ALT Obesity Device: Fibrosis Biomarkers

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort Intervention/treatment

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
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

Primary Outcome Measures :
  1. Liver and cardiovascular-related mortality [ Time Frame: 20 years ]
    Death recorded as resulting from cardiovascular or liver-related causes

Secondary Outcome Measures :
  1. Liver Cirrhosis [ Time Frame: 20 years ]
    Incidence of compensated and decompensated cirrhosis diagnosis during the study period.

  2. Cardiovascular Disease [ Time Frame: 20 years ]
    Incidence of cardiovascular disease events(defined as symptomatic coronary or cerebrovascular disease)during the study period.

  3. All-cause mortality [ Time Frame: 20 years ]
    Recording of any death during the study period

Biospecimen Retention:   Samples With DNA
Serum, whole blood and urine samples stored a -80 degrees Celsius.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A Primary Care database search (Systmone, TPP)will be performed to identify patients eligible for study (see inclusion criteria) in the discrete patient populations.

Inclusion Criteria:

  • Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease:

    • Hazardous alcohol use (>14 units/week for women, >21 units/week for men)
    • Type 2 Diabetes
    • Obesity
    • Persistently elevated ALT with normal liver serology

Exclusion Criteria:

  • Active malignancy at study enrolment
  • Inability to provide informed consent for study enrolment
  • Known presence of histologically proven liver disease prior to pilot pathway participation

Information from the National Library of Medicine

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 identifier (NCT number): NCT02037867

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United Kingdom
NIHR Nottingham Digestive Diseases Biomedical Research Unit Recruiting
Nottingham, Notts, United Kingdom, NG7 2UH
Contact: Neil Guha, MRCP, PhD    01159249924 ext 70609   
Contact: Rebecca Harris, BMedSci, BMBS    01159249924 ext 70616   
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         
Sponsors and Collaborators
University of Nottingham
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Principal Investigator: Neil Guha, MRCP, PhD University of Nottingham
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Nottingham Identifier: NCT02037867    
Other Study ID Numbers: 13029
13/EM/0123 ( Other Identifier: Research Ethics Committee (East Midlands - Leicester) )
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Keywords provided by University of Nottingham:
type 2 diabetes
abnormal liver enzymes
hepatic fibrosis
Additional relevant MeSH terms:
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Liver Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders