Topic: Hepatology
Conditions
Interventions
Blood tests will be taken from consenting participants in the study. A trained research nurse, doctor, health care assistant or phlebotomist will take the samples, often at the participant’s local hos
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patients aged under 16 years. The systems and safeguards of the study will be established in consenting adult patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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: 1. Cases of disease occur together in time and space more than expected by chance 2. Are there clusters of around key points such as industrial waste sites | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Using the disease clusters there will also be an assessment of any interaction between socio-economic status and age that leads to exposure. 2. Clusters will be mapped onto already available information e.g. changing industrial pollution through time, collieries, waste sites, metal levels/chemicals (Reference Range Study), iron works, British Geological Survey and satellite imagery. The exposure to pollution changes over people’s lives as they move and we will be able to include this information. 3. All patient participants will be asked to complete a detailed environment questionnaire and a clinical summary sheet which will provide demographic information and details about their diagnosis of AILD. Participants will also be asked to provide 1 set of blood samples but can opt out of this if they prefer. 4. A ‘best-friend’ approach will be used to gather information about people who do not have AILD. The ‘best-friends’ will be asked to complete the environment questionnaire and donate blood (optional). 5. Participants with AILD may also be asked if we can test the environment around where they live (optional). Samples from areas of high and low disease prevalence of AILD (water, air, soil, vacuum cleaner dust) may be tested for potential chemicals and toxins which might relate to disease. Any chemicals identified can be put through tests that we already have that are known to cause liver damage. 6. Chemicals/toxins may be tested for in the blood of participants with AILD and people without AILD using the ‘best-friend’ approach. | — |
Countries
United Kingdom
Outcome results
None listed