Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06247865 |
| Other study ID # |
PHU/2023/28 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Portsmouth Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The 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, the study would produce a new NHS blood test. 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, the investigators hope to understand which blood tests
help to highlight if a patient is at risk of developing irAE before it occurs.
Description:
Immune checkpoint inhibitors (ICPI) are a type of cancer treatment. Unlike traditional
chemotherapy and radiation, which damages both the cancer and the healthy tissue, ICPI
targets cancer directly by altering the immune system. Cancer cells produce high levels of
protein called checkpoint proteins, which bind to white blood cells (which are part of the
immune system) and stops them from working. Effectively the cancer is pushing a stop button
on the immune system and the body can no longer fight it off. ICPIs block and remove these
cancer checkpoint proteins, which allows the immune system to target the cancer again
removing this stop button.
ICPI has great success in treating cancer and 10% of oncology NHS patients receive this
treatment, although this number is increasing. However, ICPI carries a risk of a type of 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 treatment with ICPI develop kidney failure. It is difficult for the doctor to tell
if this is the cancer progressing or a side effect of the treatment. Delays in diagnosing
irAE can lead to unnecessary hospitalisation, unnecessary breaks in treatment, lifelong
side-effects, and death.
Currently there is not a unified blood test panel for ICPI patients, and the cancer societies
have produced little guidance for the doctors to use. At Portsmouth what blood tests you get
as an ICPI patient depend on which clinician you see. There is also little research as
researchers are focussing on using blood tests to predict ICPI treatment success rather than
the chance of a patient developing an irAE.
This study intends to collect leftover blood from routine clinical blood draws from oncology
patients being treated with ICPIs for the first time. The investigators will freeze the
leftover samples and test them a month later for different routine blood tests as well as
malondialdehyde. Malondialdehyde is a blood test that can assess the body's oxidative stress
level, a condition where your body lacks antioxidants. Testing for malondialdehyde is not
available in the NHS and we would produce a new NHS blood test as part of this study. Once
testing is completed the samples will be destroyed as per our normal protocol. At the end of
the study, blood test results will be correlated to the patient's outcome i.e., did they have
an irAE or not and assess if there are any differences in their blood test results. From this
information the study hopes to understand which blood tests help to highlight if a patient is
at a risk of developing irAE before it occurs. It also aims to develop a new method for
measuring malondialdehyde.
