Plain English Summary
Background and study aims
Non-alcoholic fatty liver disease (NAFLD) is a common liver disease present in about 25% of the adult population of the UK. 80% of people with NAFLD will not develop significant liver disease. However, in 20% of people, liver disease may progress to liver inflammation (NASH), cirrhosis and/or liver cancer. Doctors are currently unable to diagnose active liver inflammation (NASH) in NAFLD without a liver biopsy, an invasive procedure that carries a significant risk of pain and bleeding. Glyco Liver Profile is a blood test designed to measure liver inflammation without the need for a liver biopsy. It is due to be fully licensed for use in the NHS in the UK in January 2019. It is envisaged that the test would be used to aid the identification of active NASH in the NAFLD patient group. Clinical drug trials for NASH are currently recruiting participants and methods to identify people who may benefit from new drug treatments without the need for liver biopsy are urgently required. The Glyco Liver Profile blood test could avoid unnecessary invasive testing and help identify a cohort of patients who could be considered for recruitment into NASH clinical trials and may be eligible for NASH medicines once licensed. The aim of this study is to find out whether the Glyco Liver Profile is a suitable blood test for measuring liver inflammation in non-alcoholic steatohepatitis (NASH) patients.
Who can participate?
Patients with NAFLD who are having or not having a liver biopsy, and patients who don’t have NAFLD
What does the study involve?
Participants are asked to provide one blood sample at the same time as their routine clinical blood samples. Only 5 ml (one teaspoon of blood) is taken for study purposes. Participants are asked some questions (not a questionnaire but data collection form only) about their medical history and medications which does not take longer than 30 minutes. There is no further follow up.
What are the possible benefits and risks of participating?
There will be no direct benefit to participation. However, it is hoped that this study will help to improve care for patients with non-alcoholic fatty liver disease. The result of the Glyco Liver Profile blood test will be entered into the patients’ medical records and this may be of interest to the patient and add to the test results available to the liver doctor. No significant risks are expected. Only 5 ml (one teaspoon of blood) will be taken for study purposes. This blood sample will be destroyed after analysis. The patient will be asked some questions about medical history and medications which will not take longer than 30 minutes. There will be no further trial-specific intervention or follow up.
Where is the study run from?
Hull and East Yorkshire Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
April 2019 to April 2020
Who is funding the study?
Helena Biosciences Europe Limited
Who is the main contact?
Dr Lynsey Corless
lynsey.corless@hey.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lynsey Corless
ORCID ID
Contact details
Hull and East Yorkshire Hospitals NHS Trust
8th Floor Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
+44 (0)1482816776
lynsey.corless@hey.nhs.uk
Type
Scientific
Additional contact
Mrs Nurun Tania
ORCID ID
Contact details
Hull and East Yorkshire Hospitals NHS Trust
8th Floor Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
+44 (0)1482675081
nurun.tania@hey.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS: 41256
Study information
Scientific title
A pilot study to determine if the Glyco Liver Profile is a suitable candidate assay for measuring liver inflammation in non-alcoholic steatohepatitis (NASH) patients
Acronym
Study hypothesis
NAFLD is a common liver disease present in about 25% of the adult population of the UK. 80% of people with NAFLD will not develop significant liver disease. However, in 20% of people, liver disease may progress to liver inflammation (NASH), cirrhosis and/or liver cancer. We are currently unable to diagnose active liver inflammation (NASH) in NAFLD without a liver biopsy, an invasive procedure that carries a significant risk of pain and bleeding.
Glyco Liver Profile is a blood test designed to measure liver inflammation without the need for a liver biopsy. It is due to be fully licensed for use in the NHS in the UK in January 2019. It is envisaged that the test would be used to aid the identification of active NASH in the NAFLD patient group. Clinical drug trials for NASH are currently recruiting participants and methods to identify people who may benefit from new drug treatments without the need for liver biopsy are urgently required.
The Glyco Liver Profile blood test could avoid unnecessary invasive testing and help identify a cohort of patients who could be a) considered for recruitment into NASH clinical trials and b) may be eligible for NASH medicines once licensed.
Ethics approval
Approved 05/04/2019, Yorkshire & The Humber - Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; Tel: +44 (0)207 1048 088; Email: nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 19/YH/0037
Study design
Non-randomised; Observational; Design type: Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Nonalcoholic steatohepatitis (NASH)
Intervention
Patients with a diagnosis of NAFLD prospectively attending the liver clinic will be approached and asked if they would like to participate. If in agreement, they will be asked to sign a consent form. The researchers will also approach people without NAFLD who are attending a general gastroenterology clinic, to act as the normal sample group. Participation will involve an additional blood sample (5 ml) being taken at the time of routine clinical care sample collection. Participants will be asked some questions (not a questionnaire but data collection form only) about their medical history and medications which will not take longer than 30 minutes. There will be no further follow up. No other involvement or activity will be required from participants. The sample will be processed in the laboratory with routine clinical samples. The test result will return to the study team, who will store the result alongside demographic and biochemical information on an anonymised, password-protected database. The test result will also be documented in the medical records.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Journey mapping of the sample from clinic to lab to final result, to demonstrate logistical feasibility
2. Patient acceptability of having the test, assessed by direct questioning
Secondary outcome measures
Analysis of participants' Glyco and liver biopsy results, alongside other clinical data, to determine if there is preliminary evidence of correlation (not statistically powered)
Overall trial start date
22/01/2019
Overall trial end date
11/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 18 years or older on day of consent
2. Must be diagnosed with NAFLD with no liver biopsy planned (group 1)
or
Must be diagnosed with NAFLD with a planned liver biopsy (group 2)
or
Must not have a diagnosis of NAFLD (group 3)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 30; UK Sample Size: 30
Participant exclusion criteria
1. Must be less than 80 years old on day of consent
2. Unable to provide informed consent
3. Must not have a confirmed diagnosis of any liver disease other than NAFLD (group 1 and 2)
4. Must not have a diagnosis of any liver disease (group 3)
Recruitment start date
11/06/2019
Recruitment end date
11/12/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull and East Yorkshire Hospitals NHS Trust
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Sponsor information
Organisation
Hull University Teaching Hospitals NHS Trust
Sponsor details
Hull Royal Infirmary
Anlaby Road
HULL
HU3 2JZ
United Kingdom
+44 (0)1482675081
bronwen.williams@hey.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Helena Biosciences Europe Limited
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Peer-reviewed scientific journals
2. Conference presentation
3. Hospital Trust and Yorkshire and Humber Liver Network newsletters
IPD sharing statement
Data collected will be anonymised using a unique study number and will be the only identifier on the data collection form. Only the research team will know who the data belongs to. The data collected will be securely stored at the study office at Hull University Teaching Hospital. All information collected about the patient for this study will be subject to the General Data Protection Regulation and Data Protection Act 2018 for health and care research and will be kept strictly confidential. The researchers will be using information from the patient and/or medical records in order to undertake this study and will act as the data controller for this study. Hull University Teaching Hospital will keep identifiable information about the patient for 5 years after the study has finished. Hull University Teaching Hospital will keep the patient's name, NHS number and contact details confidential and will not pass this information to any other organisation. Hull University Teaching Hospital will use this information as needed, to contact participants about the research study, and make sure that relevant information about the study is recorded for care, and to oversee the quality of the study. Certain individuals from Hull University Teaching Hospital and regulatory organisations may look at participants' medical and research records to check the accuracy of the research study. These people will only receive information without any identifying information. The people who analyse the information will not be able to identify participants and will not be able to find out their names, NHS numbers or contact details. No individual participant will be identified in any publication.
Intention to publish date
11/12/2021
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN18100919_PROTOCOL_V1_21Dec2018.doc Uploaded 19/08/2019