Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062992) titled 'A Nationwide Multicenter Retrospective Registry Study of Chronic Eosinophilic Pneumonia' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Keio University

Condition: Condition - Chronic Eosinophilic Pneumonia Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - The primary objective of this study is to establish a nationwide, multicenter retrospective registry based on medical record data for idiopathic chronic eosinophilic pneumonia (CEP) to systematically characterize clinical features, diagnostic findings (clinical, laboratory, and radiological), treatment strategies (including the initiation and tapering schedules of systemic corticosteroids, as well as concomitant use of biologics), and clinical outcomes. Specifically, in addition to quantifying the real-world status of relapse-including its frequency, timing, and number of episodes - we will explore predictive factors associated with relapse using candidate variables such as comorbidities (e.g., comorbid asthma), blood and bronchoalveolar lavage (BAL) findings, CT features (scored as necessary), initial treatment intensity, and tapering speed, thereby obtaining foundational data to support relapse prediction and treatment optimization. Furthermore, considering the pathophysiological heterogeneity (including cases with comorbid asthma), we will evaluate airway morphometric parameters on diagnostic CT scans to explore their association with relapse and treatment burden. Additionally, clinically important outcomes - such as cumulative oral corticosteroid (OCS) dose, corticosteroid-related adverse events, hospitalization, and mortality - will be evaluated to generate hypotheses for future prospective studies, stratified treatment strategies, and the development of clinical practice algorithms. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients diagnosed with CEP during the data collection period (January 1, 2000, to March 31, 2026), regardless of age or sex, who meet the following criteria: 1. Meet the diagnostic criteria for CEP (A-D below), including the attending physician's comprehensive clinical judgment. 2. Have key clinical parameters (symptoms, imaging findings, blood/BAL eosinophils, treatment details, and clinical outcomes) extractable from medical records. Diagnostic Criteria for CEP (Operational Definition for This Study) * A. Presence of subacute to chronic respiratory symptoms (e.g., cough, dyspnea, wheezing, fever). * B. Chest X-ray or CT showing alveolar opacities such as infiltrates or ground-glass opacities (often peripherally predominant and/or migratory). * C. Peripheral blood eosinophilia (eosinophil count >1000/uL) or BAL eosinophilia (BAL eosinophil fraction >=25%). * D. Reasonable exclusion of other eosinophilic lung diseases or secondary causes (e.g., infections, drug-induced lung disease, parasitic infections, EGPA, ABPA/ABPM). Note: While respecting decisions made in routine clinical practice at each institution regarding diagnostic thresholds, eligibility will be evaluated against the above criteria to the extent possible. Key exclusion criteria - 1) Patients diagnosed with acute eosinophilic pneumonia (AEP). 2) Patients with confirmed or strongly suspected eosinophilic granulomatosis with polyangiitis (EGPA) or other systemic vasculitis. 3) Patients in whom secondary eosinophilia due to hypereosinophilic syndrome (HES), hematologic malignancies, or other underlying conditions is determined to be the primary cause. 4) Patients in whom diseases primarily localized to the airways, such as allergic bronchopulmonary aspergillosis (ABPA) or allergic bronchopulmonary mycosis (ABPM), are determined to be the primary cause. 5) Patients with substantially missing medical record data during the study period, making it difficult to evaluate the primary endpoint (relapse). Target Size - 300

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 03 Month 31 Day Date of IRB - 2026 Year 03 Month 31 Day Anticipated trial start date - 2026 Year 03 Month 31 Day Last follow-up date - 2036 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071911

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