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Integrated Diagnostics for Early Diagnosis of Liver Disease (ID LIVER)

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ClinicalTrials.gov Identifier: NCT04666402
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Collaborators:
University of Manchester
University of Nottingham
Innovate UK
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Alcoholic Liver Disease Liver Fibroses Other: Blood tests for Single Nucleotide Polymorphisms Diagnostic Test: Faecal microbiome analysis Diagnostic Test: Serum for diagnostic biomarkers

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Diagnostics for Early Diagnosis of Liver Disease
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


Intervention Details:
  • Other: Blood tests for Single Nucleotide Polymorphisms
    This extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
  • Diagnostic Test: Faecal microbiome analysis
    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. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
  • Diagnostic Test: Serum for diagnostic biomarkers
    Blood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.


Primary Outcome Measures :
  1. Reduction in patient numbers requiring secondary care appointments for the investigation of advanced liver fibrosis. [ Time Frame: At study completion; within 3 years ]
    Our project aims to identify patients with liver fibrosis in the community and only those with evidence of advanced fibrosis or cirrhosis being triaged on into secondary care hepatology services.


Secondary Outcome Measures :
  1. To define the metrics involved in the diagnosis of advanced liver fibrosis or cirrhosis [ Time Frame: At study completion; Within 3 years ]
    Through combining the data from basic clinical bloods such as LFTs, non-invasive scoring systems such as FIB-4 and NAFLD fibrosis scores along with the novel biomarkers, we will use this data through AI to develop algorithms that will aid the diagnosis of advanced fibrosis/cirrhosis.


Biospecimen Retention:   Samples With DNA
Serum for specific single nucleotide polymorphisms will be collected


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
Patients attending Community Liver Assessment Clinic within Manchester with deranged liver function tests, fatty liver on ultrasound or a history of alcohol excess
Criteria

Inclusion Criteria:

  • All patients referred to Community Liver Assessment Clinic.
  • Male or female > 18 years of age.
  • Females will be non-pregnant and non-lactating.

Exclusion Criteria:

  • Age < 18 years.
  • Pregnancy/breast-feeding. Women of childbearing potential (not >2 years post- menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test.
  • Isolated bilirubinaemia.
  • Known pre-existing liver disease.
  • Acutely unwell.
  • Suspected malignancy.

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 ClinicalTrials.gov identifier (NCT number): NCT04666402


Contacts
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Contact: Varinder Athwal 0161 291 5354 Varinder.athwal@manchester.ac.uk

Locations
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United Kingdom
Manchester University NHS Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9WL
Contact: Varinder Athwal       Varinder.athwal@manchester.ac.uk   
Sponsors and Collaborators
Manchester University NHS Foundation Trust
University of Manchester
University of Nottingham
Innovate UK
Investigators
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Principal Investigator: Varinder Athwal Manchester University NHS Foundation Trust/Manchester University
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Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04666402    
Other Study ID Numbers: B00907
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders