Study on Biomarkers of Immune-Related Adverse Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Immune-Related Adverse Events. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Immune-Related Adverse Events [Time frame: 2 years]
Secondary outcome measures (1)
- overall survival [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age >18 years;
- Karnofsky Performance Status (KPS) >60;
- Expected to receive at least one cycle of immune checkpoint inhibitor therapy;
- Expected survival >6 months.
Exclusion criteria
- Prior treatment with immune checkpoint inhibitors;
- Active autoimmune diseases (including systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, scleroderma, etc.);
- Use of systemic immunosuppressive agents within 14 days prior to enrollment (prednisone >10 mg/day or equivalent);
- Inability to provide biological samples.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07527585 · TJ202601080