NCT07527585

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for all trials

Timeline
80mo left

Started Apr 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Dec 2032

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

6.7 years

First QC Date

April 7, 2026

Last Update Submit

April 7, 2026

Conditions

Immune-Related Adverse Events

Outcome Measures

Primary Outcomes (1)

  • Immune-Related Adverse Events

    Immune-Related Adverse Events

    2 years

Secondary Outcomes (1)

  • overall survival

    5 years

Study Arms (1)

Patients with malignancies receiving immunotherapy

Patients with malignancies receiving immunotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with malignancies undergoing immunotherapy

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Lingyan Xiao

CONTACT

027-15971474885lingyanxiao@hust.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share