Cutaneous immune-related adverse event
Conditions
Interventions
Training Set:None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients with solid tumors who received immune checkpoint inhibitor treatment in the Department of Oncology at Zhongshan Hospital affiliated with Fudan University between January 1, 2020, and September 30, 2025; 2. Adult patients with solid tumors who received any ICI regimen (anti-PD-1/PD-L1/CTLA-4, monotherapy or combination therapy); 3. Must have laboratory test records within 24 weeks before ICI treatment (baseline) or within 2 to 12 weeks after ICI treatment (early post-treatment); 4. Must have at least 24 weeks of follow-up post-treatment, enabling the determination of skin adverse event outcomes; 5.Relevant clinical information, after data extraction and structuring, must meet the minimum key dataset requirements needed for predictive model construction, including demographic characteristics, basic tumor information, medication usage, and core laboratory indicators; 6.Previously signed informed consent for biobank sample donation, agreeing to donate their samples and data for all medical research.
Exclusion criteria
Exclusion criteria: 1. Key clinical information or laboratory test data are missing, and even after retrospective medical record review or follow-up cannot be completed, making it impossible to meet the minimum key dataset requirements necessary for predictive model construction; 2. Lack of clear follow-up records, making it impossible to determine whether immune-related skin adverse reactions occurred, or to accurately determine their time of occurrence and severity; 3.Having pre-existing active, systemically treated severe skin diseases before receiving immune checkpoint inhibitors, whose clinical manifestations are difficult to distinguish from subsequent skin adverse reactions, making it impossible to determine the occurrence or severity of immune-related skin adverse reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether cutaneous immune-related adverse event occurred; | — |
Countries
China
Contacts
Public ContactJi Yang
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed