Checkpoint inhibitor-related pneumonia
Conditions
Interventions
Gold Standard:Diagnosis of checkpoint inhibitor-related pneumonitis (CIP) is based on the Clinical Guidelines for the Diagnosis and Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis. Confir
Index test:Proteomic mass spectrometry detection of peripheral blood samples to screen and verify specific protein biomarkers for CIP, and evaluate their diagnostic performance.
Sponsors
The second hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All participants must meet the following conditions at the same time: 1. Patients aged between 18 and 80 years. 2. Patients whose lung cancer diagnosis is confirmed by bronchoscopy or lung biopsy pathology. 3. Lung cancer patients receiving immunotherapy (PD1/PDL1 inhibitors). 2. Inclusion criteria for the CIP group: (1) According to the 'Expert Consensus on the Diagnosis and Management of Immune Checkpoint Inhibitor-Related Pneumonia (2025)' published in the Chinese Journal of Tuberculosis and Respiratory Diseases in 2025, lung cancer patients who develop new or worsening fatigue, fever, cough, chest pain, shortness of breath, or other symptoms after ICI immunotherapy, and new lung shadows shown in imaging. (2) CIP-related treatments such as corticosteroids are effective. 3. Inclusion criteria for the non-CIP group: (1) Lung cancer patients who do not develop CIP after ICI immunotherapy. (2) Immunotherapy cycles >= 4 cycles.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for the CIP group (1) Interstitial lung disease caused by combined lung infection, lung tumor progression, pulmonary edema, or other reasons. (2) Combined with other malignant tumors or metastatic tumors. (3) Received radiotherapy during treatment. 2. Exclusion criteria for the non-CIP group (1) Immunotherapy cycles less than 4 cycles. (2) Missing medical history information or follow-up treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of checkpoint inhibitor-related pneumonitis (CIP);Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactLi Encheng
The second hospital of Dalian Medical University
Outcome results
None listed