Identifying blood biomarkers to predict immune-related side effects in cancer patients
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)
This study is trying to see if certain blood tests can help predict immune-related side effects in cancer patients who are receiving new immune treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Drugs / interventions | ipilimumab, nivolumab, pembrolizumab, cemiplimab, atezolizumab, avelumab, durvalumab, chemotherapy, radiation |
| Locations | 1 site (Portsmouth, Hampshire) |
| Trial ID | NCT06247865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect leftover blood samples from oncology patients receiving immune checkpoint inhibitors (ICPI) to analyze routine blood tests and malondialdehyde levels. The goal is to assess the relationship between these biomarkers and the occurrence of immune-related adverse events (irAEs) in patients. By correlating blood test results with patient outcomes, the study seeks to identify which tests can indicate a higher risk of developing irAEs before they manifest. Ultimately, this could lead to the development of a new blood test panel for ICPI patients in the NHS.
Who should consider this trial
Good fit: Ideal candidates for this study are adult oncology patients who are prescribed FDA-approved immune checkpoint inhibitors.
Not a fit: Patients under 18, those with a history of autoimmune or endocrine diseases, or those previously treated with checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier identification of patients at risk for serious side effects from cancer treatment, potentially improving patient safety and outcomes.
How similar studies have performed: While there is limited guidance on unified blood tests for ICPI patients, this approach is novel and aims to fill a significant gap in current cancer treatment protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portsmouth, Hampshire
- Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital — Portsmouth, Hampshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.