Checkpoint Inhibitor-Induced Liver Injury (ChILI)

If your specialist cancer doctor (oncologist) has advised you to start taking checkpoint inhibitors for your cancer or if you are already on the treatment and developed liver injury (ChILI), we will arrange to see you as soon as possible. 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 via e-consent.

Your participation is voluntary and you are free to withdraw at any time, without giving a reason, and without your medical care or legal rights being affected. If you decide to withdraw, then some information collected 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. 

If your specialist cancer doctor (oncologist) has advised that you start you on checkpoint inhibitors for your cancer or if you are already on the treatment and developed liver injury (ChILI), we will arrange to see you as soon as possible. We expect to see you 2-3 times over a month.

• Duration: Each visit is expected to last about 30 minutes.

• Location: At the ward, outpatient department or research centre in Nottingham University Hospitals (Queens Medical Centre (QMC) and Nottingham City Hospital) or St George’s Hospital or Derriford Hospital.

What happens during the visit:

• The research nurse will answer any questions you have and ask you about your health and medical history including your medications.

• We will collect up to 80 mls of blood (4½ tablespoons) for research and ask if you can provide a urine and/or stool sample (optional).

• Samples for research will be collected alongside your clinical care blood tests. Visits will be adapted to coincide in with your routine hospital care and clinic visits whenever possible.

We will not change your cancer treatments or test any new drugs or treatment

Blood samples: We expect to take 35mls (2 tablespoons) for research but at one or two visits we may request an additional 30mls of blood. Where possible we can take this extra blood at a separate time to suit you or at the same time as your clinical blood tests (maximum of 80mls including clinical bloods, equivalent to 4½ tablespoons). Additional blood will enable us to carry out specialised antibody tests on particular immune cells which could help us to distinguish ChILI from other liver injuries.

Liver biopsy: If you developed ChILI, the clinical team might consider a liver biopsy to guide management. If you consent, we would request to use any surplus tissue for research. Samples (blood and tissue) might be sent to specialist centres for analysis, either in the UK or abroad (e.g.Pfizer, USA). We will measure various constituents of your blood, urine and stool (e.g. the biochemical substances and types of cells present, the biological processes occurring and DNA features).

Retaining samples for future use: We would like to ask for your consent to store any samples leftover at the end of this study to use them in future research – it is optional. The samples will be stored with a code unique to you and securely at the University of Nottingham (Nottingham Digestive Diseases Centre) and made available for future studies by researchers here or at other institutions. Samples and data used will be anonymised and you will not be identified in anyway.

This study will not directly benefit you, but the information we get from this study may help future cancer patients receiving checkpoint inhibitors.

We are not altering your treatment regime or testing new drugs. We will simply monitor your health and responses to your treatment requiring additional time at appointments. Blood sample collection may cause temporary discomfort and occasionally a bruise. It will be performed by trained personnel only and we don’t expect any complications.