Glyco Liver Profile Feasibility Study
Research type
Research Study
Full title
A pilot study to determine if the Glyco Liver Profile is a suitable candidate assay for measuring liver inflammation in Non Alcoholic Steato-Hepatitis (NASH) patients
IRAS ID
259722
Contact name
Bronwen Williams
Contact email
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
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 significant risk of pain and bleeding. \n\nGlyco 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 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.\nThe 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.\nWe aim to recruit 30 participants: 10 patients with NAFLD;10 patients with NAFLD having a liver biopsy; 1o patients who don’t have NAFLD but will join the study as a control subject.\nParticipants will be asked to fill to provide one blood sample at the same time as their routine clinical blood samples. Only 5mls (one teaspoon of blood) will be taken for study purposes. \nParticipants 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. \n\n\n
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0037
Date of REC Opinion
5 Apr 2019
REC opinion
Further Information Favourable Opinion