Tokyo, May 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061510) titled 'A Prospective Observational Study on the Utility of Rapid GM-CSF Autoantibody Testing (LineCheck APAP) in Patients with Undiagnosed Diffuse Pulmonary Ground-Glass Opacities' on May 30.

Study Type: Observational

Primary Sponsor: Institute - Kumamoto University

Condition: Condition - Undiagnosed diffuse lung diseases presenting with diffuse ground-glass opacities on HRCT Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate whether rapid qualitative assay for GM-CSF autoantibodies using KBM LineCheck APAP at the initial visit contributes to early diagnosis of autoimmune pulmonary alveolar proteinosis (APAP) and to assess the diagnostic utility of the test in patients with unconfirmed diffuse lung diseases (DLDs) presenting with diffuse ground-glass opacities (GGOs) on HRCT. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients evaluated or treated at Kumamoto University Hospital, Kyoto University Hospital, Kyorin University Hospital, Institute of Science Tokyo Hospital, Chiba University Hospital, Saitama Red Cross Hospital, or Tohoku University Hospital; 2) 18 years and older; 3) undiagnosed DLDs presenting with diffuse GGOs on HRCT at the initial visit; and 4) patients who received a written explanation of the study and provided written informed consent. Key exclusion criteria - 1) Patients with an obvious mass lesion or localized nodular lesion; 2) patients with an acute clinical course showing rapid progression within 1 month; 3) patients with an already identified cause of DLD, such as drug-induced lung injury; 4) patients with overt cardiac disease causing pulmonary congestion, such as heart failure; 5) cases judged to be inappropriate for participation by the treating physician at the time of HRCT assessment; and 6) patients currently participating in another interventional study that precludes participation in this study. Target Size - 350

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 30 Day Anticipated trial start date - 2026 Year 05 Month 30 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069927

Disclaimer: Curated by HT Syndication.