NCT07527585

Study on Biomarkers of Immune-Related Adverse Events

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 440 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1. To identify biomarkers of immune-related adverse events; 2. To develop a predictive model for immune-related adverse events.

Detailed description

1. Enroll eligible patients and obtain written informed consent. 2. Collect clinical data. 3. Sample collection and biomarker assessment: Peripheral blood samples will be collected from patients before the initiation of immunotherapy and after the start of immunotherapy, followed by multi-omics analyses. 4. Patient follow-up: Patients will be followed within 1 month after the first cycle of immunotherapy and every 3 months thereafter; after 1 year, follow-up will be conducted every 6 months. Patients' symptoms, laboratory tests, and examination findings will be recorded. Immune-related adverse events (irAEs) and their grading will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. In addition, treatments and outcomes after the occurrence of irAEs will be documented. The primary endpoint is immune-related adverse events, and the secondary endpoint is overall survival. 5. Data integration: Clinical data, previous research findings, and biomarkers measured from patient samples will be integrated to identify biomarkers of immune-related adverse events and to develop a predictive model using bioinformatics approaches.

Conditions

• Immune-Related Adverse Events

Timeline

• Start date: 2026-04-01
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14