Study on Biomarkers of Immune-Related Adverse Events

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07527585

Enrollment

440

Registered

2026-04-14

Start date

2026-04-01

Completion date

2032-12-01

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune-Related Adverse Events

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age \>18 years; 2. Karnofsky Performance Status (KPS) \>60; 3. Expected to receive at least one cycle of immune checkpoint inhibitor therapy; 4. Expected survival \>6 months.

Exclusion criteria

1. Prior treatment with immune checkpoint inhibitors; 2. Active autoimmune diseases (including systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, scleroderma, etc.); 3. Use of systemic immunosuppressive agents within 14 days prior to enrollment (prednisone \>10 mg/day or equivalent); 4. Inability to provide biological samples.

Design outcomes

Primary

Measure	Time frame	Description
Immune-Related Adverse Events	2 years	Immune-Related Adverse Events

Secondary

Measure	Time frame
overall survival	5 years

Contacts

CONTACTLingyan Xiao

lingyanxiao@hust.edu.cn027-15971474885

Outcome results