Identification of genetic factors that predispose to immune checkpoint inhibitor toxicity

Study ID: 39433
Short Title: ICI Genetics
Trust Name: HHFT,UHD
Recruitment Site: Poole Hospital,Royal Hampshire County Hospital
Disease Area: Colorectal cancer Lung cancer Urology
Phase: N/A
Expected End Date: 31/03/2024
Postcode: RG24 9NA
SO22 5DG
BH15 2JB
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Patients that have been treated with Immune Checkpoint Inhibitors for any malignancy. Able and willing to provide informed consent and a sample of blood (or saliva). Aged 16 or over. Family members of participants with autoimmune disease.

Unable or unwilling to provide informed consent and a sample of blood (or saliva) Aged less than 16 years old

THIS STUDY WILL RECRUIT PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS FOR ALL FORMS OF CANCER Immune Checkpoint Inhibitor Genetics Summary Title: Toxicites caused by immune checkpoint inhibitors used to treat cancers: are there differences in the genetic make-up of those patients who suffer side effects and those who do not? All anti-cancer therapies cause toxicity and some individuals appear especially susceptible to the side-effects of particular treatments. This might be because of genes that we inherit. We can find out whether those genes exist by studying the clinical features and blood samples of a large set of cancer patients who have been treated with immune system boosters and looking for differences between those who develop severe toxicity, those who have mild toxicity and those who have no toxicity. We can also look at people with different types of toxicity, for example affecting different parts of the body. We will also study the clinical features and bloods samples of a group of participants who have autoimmune diseases but have not been treated with immune system boosters to assess whether there are any similarities in their inherited genes. If we find genes that affect the chances of toxic side-effects, we may be able to find out who is at greatest risk before they take the drugs and develop ways of preventing or minimising the side-effects. Clinical details will be collected from the participant and clinical team in the form of a questionnaire, blood sampling will occur on a single occasion, either within routine clinical management or at the participants convenience.

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