Long and Short-Term effects of Standard-of-Care treatments for Cancer
Research type
Research Study
Full title
An investigation describing the Long and Short-Term effects of Standard-of-Care treatments for people with Cancer
IRAS ID
193937
Contact name
Neil Steven
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Immune checkpoint inhibitors (ICPI) are drugs that release cancer immunity. ICPI cause immune attack on normal organs resulting in immune related adverse events (IrAE) including bowel inflammation called immune related colitis (IR-colitis). We will describe the clinical and pathological features of IR-colitis, exploring a role for viruses including Epstein Barr virus (EBV) which lives harmlessly in most people. More broadly, the study will explore clinical, pathological and microbiological features associated with ICPI treatment, cancer control and IrAE.\n\nAt the University Hospitals Birmingham, we will recruit fifty consenting people treated with ICPI at standard of care clinic appointments. We will take scheduled blood and body product samples before during and after treatment induction. Also, we will recruit groups of around ten consenting patients for particular experiments, requesting unscheduled samples. This may include additional tissue sampling during standard procedures or additional non-invasive biopsies. These may include people presenting with IR-colitis, treated with ICPI, with other IrAE, with cancer without ICPI treatment, with colitis for other reasons, and healthy volunteers. Samples from these groups may be used to characterise the values or variation of particular measurements to better understand their meaning in the main cohort.\n\nRetrospective clinical data and archival pathology samples surplus to clinical need will be explored in relation to specific questions relating to ICPI treatment, IrAE and cancer control within scope of the project. In particular, we will focus on data and samples relating to previous episodes of IR-colitis, inflammatory bowel disease and EBV-lymphoproliferation and will seek evidence of reactivation of EBV and other viruses. At NHS centres in England and Wales, clinical data with linked archival tissue will be collated by clinical care teams. Fully anonymised data and material will be analysed at the University of Birmingham. Consent will not be sought for use of fully anonymised data and samples. [COVID-19 amendment – 09/04/2020] As a result of COVID-19, We have made some amendments which allow us to look specifically at SARS-CoV-2 and permit consent over the telephone. This is in keeping with the current clinical practice whereby clinical consultations are being conducted over the telephone. It will also ensure we are falling in line with the Government social distancing policy. New consent forms,PIS, GP letters, and recruitment emails to be used over the COVID-19 Pandemic.\n\n[COVID-19 amendment – 28/04/2020]\n\nWe are submitting an additional workplan comprising consent post-mortem examinations on deceased patients in which COVID-19 was the primary cause of death, or, a significant contributing factor in cancer or non-cancer patients, and patients with cancer who died following an acute respiratory illness. The workplan also covers the acquisition of archival tissue from existing post-mortems of COVID-19 cases, cancer patients, cancer therapy related deaths and appropriate controls (normal tissue/ other inflammatory infectious diseases) in which there is consent for the tissue to used in ethically approved research. We will also seek post-mortem tissue which match the above criteria from HTA approved biorepositories. Associated clinical data will be collated by means of a standardised proforma. Tissue that is acquired by these means will be sent to the University of Birmingham for further investigation with linked clinical data in a fully anonymised form. Where appropriate, anonymised tissue will be sent from the University of Birmingham to other laboratories in the UK, Europe of USA for specific experiments. Where appropriate consent exists, surplus tissue will be utilised in other ethically approved studies or donated to a tissue bank. Alternative arrangements for surplus tissue will be enacted where specified by the consent giver.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0336
Date of REC Opinion
10 Nov 2019
REC opinion
Favourable Opinion