Environmental factors in the aetiology of AutoImmune Liver Disease

Not Applicable

Completed

• Conditions: Topic: Hepatology; Subtopic: Hepatology; Disease: All Hepatology; Digestive System

• Registration Number: ISRCTN48732084
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33474546/ (added 22/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-24
• Study Completion: 2017-12-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2622

Inclusion Criteria

1. All adult patients with a diagnosis of Primary Biliary Cirrhosis (PBC), Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) in Northern England who are able to give informed consent
2. The small minority who cannot give informed consent are not otherwise different from the rest of the study population, so have the potential to benefit from study outputs without the need to participate
3. 'Best-friend' participants will be adults of the same gender and similar age to patient participants who are not affected by liver disease

Exclusion Criteria

Patients aged under 16 years. The systems and safeguards of the study will be established in consenting adult patients

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> This is an observational study so there is no 'outcome' measure as such. A comprehensive case-finding approach will be used to identify all cases of AILDs in Northern England by developing a comprehensive database. The primary outcome measure will be whether there are disease clusters of cases in time and space.<br><br> All participants will be asked to complete the environment questionnaire and donate blood at time of recruitment to the study. This will be the only time they provide samples. The environment questionnaire data will be analysed at a later time point in the study. The blood samples will be tested later in the study when a suitable number of samples have been collected. Statistical modelling will be conducted on the database to assess if:<br> 1. Cases of disease occur together in time and space more than expected by chance<br> 2. Are there clusters of around key points such as industrial waste sites<br>