BIO-CHECKPOINT
Research type
Research Study
Full title
Characterising biomarkers and clinical algorithms to identify oncology patients on immune checkpoint inhibitors (ICPI) that are at greater risk of developing immune-related adverse events (irAE).
IRAS ID
329576
Contact name
Louise Duvall
Contact email
Sponsor organisation
Portsmouth Hospital University NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Immune checkpoint inhibitors (ICPI) are a cancer treatment, which alters the immune system. Cancer cells produce high levels of protein called checkpoint proteins that push a stop button on the immune system. ICPIs block and remove these cancer checkpoint proteins, which allows the immune system to target the cancer again removing this stop button.
10% of NHS cancer patients are on ICPIs, although this number is increasing. However, ICPI carries a risk of a side effect called immune-related adverse events (irAE). irAEs can be life-threatening and present with similar symptoms to the patient’s cancer. For example, a patient may have kidney cancer and after ICPI treatment develop kidney failure. It is difficult to tell if the cancer has progressed or if it’s a treatment side-effect. Delays in diagnosing irAE can lead to unnecessary hospitalisation, lifelong side-effects, and death.
Currently, there is little guidance and no unified blood test panel for ICPI patients. What blood tests ICPI patients receive depends on the doctor. Research is currently mostly focussing on blood tests predicting ICPI treatment success rather than irAE risk.
Our study will collect leftover clinic blood samples on new oncology ICPI patients and test them for routine blood tests and malondialdehyde. Malondialdehyde can assess the body’s oxidative stress level, a condition where your body lacks antioxidants. The NHS does not offer a malondialdehyde test presently, we would produce a new NHS blood test for this study. Once testing is completed the samples will be destroyed. Blood test results will be correlated to the patient’s outcome i.e., did they have an irAE and assess if there are any differences in the results. From this information, we hope to understand which blood tests help to highlight if a patient is at risk of developing irAE before it occurs.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0224
Date of REC Opinion
19 Jul 2023
REC opinion
Favourable Opinion