Clinical trial · Observational
BIO-CHECKPOINT 0 Biomarkers to Identify Oncology Patients on ICPI at Greater Risk of irAE
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Prediction of patient risk of irAE.
- timeFrame
- 2 years
- description
- A calculation or clinical flow chart that can accurately predict patient's at risk of onset of irAE using routine blood tests and novel biomarkers. Sensitivity, specificity will be calculated and ROC curves.
Secondary outcomes (3)
- measure
- Significant difference in any established biochemistry, haematology and immunology blood tests in those who develop irAE when compared to those that don't.
- timeFrame
- 2 years
- description
- Significant difference (p\<0.05) in blood test results (concentrations) of those who develop an irAE, opposed to those who don't. Tests include but not limited too: interleukin 6, haptoglobin, C-reactive protein, Beta 2 macroglobin, complement proteins (C3 and C3), lactate dehydrogenase, ferritin, etc.
- measure
- Valid liquid chromatograph method fit for clinical laboratory use.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * Oncology patients * Who is prescribed FDA approved check point inhibitors: (ipilimumab, nivolumab, pembrolizumab, cemiplimab, atezolizumab, avelumab, and durvalumab) * All cancer subtypes are included Exclusion Criteria: * \<18 years of age * Those previously been treated with checkpoint inhibitors. * Those with a previous medical history of autoimmune disease * Those with previous medical history of endocrine diseases * Those with a pre-existing malignancy * Non-Queen Alexandra hospital oncology patients * Lacking capacity to consent
References
Publications (0)
Data not yet available