Study on Biomarkers of Immune-Related Adverse Events

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

Study Overview

• Status: Not yet recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 440

Contacts and Locations

• Study Contact: Name: Lingyan Xiao; Phone Number: 027-15971474885; Email: lingyanxiao@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with malignancies undergoing immunotherapy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with malignancies receiving immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune-Related Adverse Events	Immune-Related Adverse Events	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	5 years

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TJ202601080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No