BIO-CHECKPOINT 0 Biomarkers to Identify Oncology Patients on ICPI at Greater Risk of irAE

NCT06247865 | Completed

• 1 other identifier: PHU/2023/28
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncology patients, whom have been prescribed ICPIs for the first time, will be identified via the chemotherapy scheduling system.

You may qualify if:

• ≥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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 8, 2024
• Study Start: March 1, 2024
• Primary Completion: October 23, 2024
• Study Completion: May 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)