Immune checkpoint inhibitor-related pneumonitis and other newly developed acute pulmonary diseases in cancer patients
Conditions
Interventions
None listed
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Retrospective observational study: Patients who were diagnosed with malignant tumors at Hamamatsu University School of Medicine Hospital and initiated immune checkpoint inhibitor therapy as part of routine clinical practice between September 2014 and March 2025, and who were subsequently diagnosed with immune checkpoint inhibitor-related pneumonitis. In addition, patients who received clinical care for newly developed pulmonary lesions during the same period (September 2014 to March 2025). Pooled analysis: Patients registered in the following studies approved by the Institutional Review Board of Hamamatsu University School of Medicine (Hamamatsu, Japan): Clinical Features and Outcomes of Pneumonitis related Anti-Programmed Death-1 therapy in Non-Small Cell Lung Cancer Patients (Study No. 19-037) Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study (Study No. 19-037)
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria will be excluded from the study: Patients who withdrew or refused consent for the use of their information for this study, either by themselves or through a legally authorized representative. Patients in whom serum KL-6 and SP-D were not measured.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of optimal cutoff values for KL-6 and SP-D in the differential diagnosis between immune checkpoint inhibitor-related pneumonitis and other pulmonary disease. Diagnostic accuracy of KL-6 and SP-D when their established normal upper limits are used as cutoff values. | — |
Countries
Japan
Contacts
Public ContactShogo Nakai
Hamamatsu University School of Medicine Second Division, Department of Internal Medicine
Outcome results
None listed