What is the purpose of this study?
Since DILI is rare, caused by many different medications and diet supplements and highly variable, it is very difficult to study. In order to understand the disease a large collection of patients is needed to investigate the disease features. This means an International collaboration is necessary to achieve our goal.
The purpose of this study is to set up an international interdisciplinary consortium to obtain a better understanding of the mechanisms underlying DILI and to develop methods of preventing DILI and its consequences.
What will I be asked to do?
A nurse from the research team will visit you on the ward or arrange an appointment for you at your treatment centre/hospital (if possible at the same time as your medical appointment). You will be given a reasonable amount of time to read the patient information booklet and adequate opportunity to consider enrolment before being approached for consent by the research team.
If you decide to take part, you will be asked to sign a consent form to confirm you understand what is involved. This may be done face-to-face or over the telephone.
Your participation is voluntary and you are free to withdraw at any time, without giving any reason, and without your medical care or legal rights being affected.If you withdraw then some information collected so far cannot be erased and this information may still be used in the project analysis. Based on your study code assigned by your research team, we will contact the database and sample managers or biobanks to remove any associated data and samples that remain if you wish. However it may not be possible to destroy samples already sent for analysis.
We will not inform your GP about your participation in this study since it has no effect on your care and provides no information about your health.
1- We will provide information about the study for you to consider and offer an appointment with our nurse.
2- Our nurse will meet with you to discuss your health, the study and collect samples
3- You will have a clinical follow up until the liver recovers, or 12 weeks after the first event, whichever occurs later.
If you are suspected of having DILI, we will arrange an appointment to see you as soon as possible. We expect to see you 2-3 times over 30 days then after 3 & 6 months if your symptoms remain. Each visit is expected to last about 30 minutes.
We would like to take samples from all patients at recruitment as well as after 1 week and 1 month.
• If you are an in-patient, we will collect additional data and samples on 1-2 additional days during your period of hospitalization.
• If your liver functioning has not returned to normal, you will be asked to return after 3 months and after 6 months.
• Visits will be adapted to fit in with (coincide or replace) your routine hospital care and clinic visits whenever possible.
• Samples for research will be collected alongside your clinical care blood tests.
• If you have a liver biopsy as part of your clinical care, we will also ask you if we can use any surplus sample material leftover afterwards for future research.
Following recruitment, if your symptoms are later found to be due to other causes (and not to be due to medications), you are still eligible to continue to take part in the study. Your samples are valuable to compare to those from DILI patients.
What will happen to my samples?
We will send samples to research teams at other institutions for collaborative research, or to commercial service providers for specialist analysis. These may be within or outside the UK. All samples and medical details will be anonymised so you cannot be identified. We will comply with the Human Tissue Act and other International laws.
During each study visit, no more than 80ml, in total, will be taken for any clinical tests you need and research. Generally we expect to take 35ml for research but at one or two of these visits we may request an additional 30mls of blood. Where possible we can take this extra blood at a separate appointment/time to suit you or at the same time as your clinic bloods. Additional blood will enable us to carry out specialised antibody tests on particular white blood cells (immune cells) which could help us to distinguish DILI from other forms of liver injury where the immune system attacks the liver cells.
Various substances and constituents of your blood, urine and stool will be measured. Your blood samples will be analysed to look at DNA & gene variations which may contribute to DILI, if you agree. We will not carry out clinical genetic testing of your samples to detect known inherited disorders.
Where is this research study being done?
We have hospitals across the UK recruiting to this study:
- Nottingham University Hospitals NHS Trust, Nottingham
- Queen Alexandra Hospital, Portsmouth
- Royal Free Hospital, London
- Basingstoke and North Hampshire Hospital
- Derriford Hospital, Plymouth
- Addenbrookes Hospital, Cambridge
- Ninewells Hospital, Dundee
- Royal Cornwall Hospital, Cornwall
- Queen Elizabeth Hospital, Birmingam
- Aberdeen Royal Infirmary
- Homerton Hospital, London
- Univeristy Hospital Southampton
Please view the Patient Information Sheet for more information