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)
Sponsor study identifier
observational
120
1 country
1
Study Start
March 1, 2024
Actual (reported)Primary Completion
October 23, 2024
Actual (reported)Study Completion
May 1, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2024
Actual (reported)February 8, 2024
Actual (reported)March 1, 2024
Actual (reported)October 23, 2024
Actual (reported)May 1, 2025
Actual (reported)Prediction of patient risk of irAE.
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.
2 years
Significant difference in any established biochemistry, haematology and immunology blood tests in those who develop irAE when compared to those that don't.
2 years
Valid liquid chromatograph method fit for clinical laboratory use.
2 years
Significance of Malondialdehyde results.
2 years
Oncology patients, whom have been prescribed ICPIs for the first time, will be identified via the chemotherapy scheduling system.
Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
120 participants (actual enrollment reported by the registry).
First Submitted
January 17, 2024
First Posted
February 8, 2024
Study Start
March 1, 2024
Actual (reported)68Ga-JH04 PET/CT in Patients With Various Types of Cancer
Contact the study team to confirm eligibility.
Primary Completion
October 23, 2024
Actual (reported)Study Completion
May 1, 2025
Actual (reported)Last Updated
July 17, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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