Tokyo, Jan. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060291) titled 'Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis' on Jan. 7.

Study Type: Observational

Primary Sponsor: Institute - Hamamatsu University School of Medicine

Condition: Condition - Immune checkpoint inhibitor-related pneumonitis and other newly developed acute pulmonary diseases in cancer patients Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the utility of KL-6 and SP-D in the differential diagnosis between immune checkpoint inhibitor-related pneumonitis and other pulmonary diseases presenting with lung lesions. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key 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) Key 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. Target Size - 200

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 07 Month 01 Day Date of IRB - 2025 Year 07 Month 07 Day Anticipated trial start date - 2025 Year 07 Month 08 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068967

Disclaimer: Curated by HT Syndication.