Immune-Related Adverse EventsNCT07527585
Study on Biomarkers of Immune-Related Adverse Events
An observational study of Immune-Related Adverse Events, run by Huazhong University of Science and Technology.
Trial summary
1. To identify biomarkers of immune-related adverse events; 2. To develop a predictive model for immune-related adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune-Related Adverse Events
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with malignancies undergoing immunotherapy
Who may be able to join
- Age >18 years;
- Karnofsky Performance Status (KPS) >60;
- Expected to receive at least one cycle of immune checkpoint inhibitor therapy;
- Expected survival >6 months.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- To identify biomarkers of immune-related adverse events;
- To develop a predictive model for immune-related adverse events.
Read the detailed description
- Enroll eligible patients and obtain written informed consent.
- Collect clinical data.
- 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.
- 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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignancies receiving immunotherapy | Patients with malignancies receiving immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune-Related Adverse Events
Immune-Related Adverse Events
Measured: 2 years
Secondary outcomes (1)
overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune-Related Adverse EventsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianglin Yuan, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527585
- Sponsor's protocol ID
- TJ202601080
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Biomarkers of Immune-Related Adverse Events
- ClinicalTrials.gov ID
- NCT07527585
- Acronym / sponsor ID
- TJ202601080
- Conditions
- Immune-Related Adverse Events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To identify biomarkers of immune-related adverse events;
- To develop a predictive model for immune-related adverse events.
Detailed description
- Enroll eligible patients and obtain written informed consent.
- Collect clinical data.
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignancies receiving immunotherapy | – | –Patients with malignancies receiving immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with malignancies undergoing immunotherapy
Key inclusion criteria (4 listed)
- Age >18 years;
- Karnofsky Performance Status (KPS) >60;
- Expected to receive at least one cycle of immune checkpoint inhibitor therapy;
- Expected survival >6 months.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune-Related Adverse Events
Time frame: 2 years
Immune-Related Adverse Events
1 secondary outcome
overall survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-Related Adverse Events, run by Huazhong University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingyan Xiao (027-15971474885, lingyanxiao@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune-Related Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.