Study on Biomarkers of Immune-Related Adverse Events

Huazhong University of Science and Technology

Status: Not yet enrolling

Conditions: Immune-Related Adverse Events

Study type: Observational

Funder types: Other

Identifiers

NCT07527585

TJ202601080

Details and patient eligibility

About

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

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

440 participants in 1 patient group

Patients with malignancies receiving immunotherapy

Description:

Patients with malignancies receiving immunotherapy