Immune checkpoint inhibitor associated pneumonia
Conditions
Interventions
Gold Standard:1. History of ICIs administration
2. Newly emerged pulmonary opacities
3. Diagnosis of CIP based on medical history, serological tests, etiological screening, bronchoscopy findings, and chest CT manifestations, after excluding pulmonary infection, progression of lung can
Index test:Exhaled breath volatile organic compound
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, regardless of gender. 2. Histologically confirmed patients with advanced non-small cell lung cancer (NSCLC) with stage IIIB or IV disease (assessed according to the 8th edition of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) at initial diagnosis. 3. Patients scheduled to receive first-line immunotherapy. 4. No history of other malignancies within the previous 5 years and no prior anticancer treatment. 5. Voluntary participation in the study with signed informed consent, good compliance, and willingness to comply with follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of active infection or liver disease. 2. Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or any other antibodies or drugs targeting T-cell co-stimulation or immune checkpoint pathways. 3. Poorly controlled diabetes mellitus, hyperthyroidism, rheumatic immune diseases, or other conditions that may affect metabolomic testing; neurological or neuropsychiatric disorders; subjects with other active malignancies requiring concurrent treatment. 4. Concomitant radiotherapy, PTS, or other local therapeutic measures. 5. Patients judged by the investigator to be ineligible for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of biomarkers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;specificity;predictive value; | — |
Countries
China
Contacts
Public ContactLin Xinqing
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed