Tokyo, Oct. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063357) titled 'National Hospital Organization Severe Hypereosinophilia Interspecialty Nationwide Elucidation Prospective Study' on Oct. 21.

Study Type: Observational

Primary Sponsor: Institute - National Hospital Organization Sagamihara National Hospital

Condition: Condition - Marked peripheral blood eosinophilia (absolute eosinophil count at least 1,500 cells per microliter) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This multicenter observational study aims to investigate the distribution of final diagnoses, clinical characteristics, and diagnostic trajectories among adults with peripheral blood eosinophil counts at least 1,500 cells per microliter across National Hospital Organization (NHO) hospitals and collaborating institutions in Japan. A retrospective survey of all eligible patients at participating institutions will also be conducted to characterize the distribution of underlying diseases. Furthermore, comprehensive proteomic and cytokine analyses of blood and urine samples will be performed to explore novel biomarkers for differentiating eosinophilic disorders, including eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES). Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Study A-1 (Prospective registry) 1. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter confirmed at least once. 2. Patients aged 20 years or older at the time of informed consent. 3. Patients who provide written informed consent to participate in the study.

Study A-2 (Retrospective survey) 1. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter. 2. Patients aged 20 years or older. 3. Patients who visited a participating institution during the one-year period preceding the designated data extraction date.

Study B (Exploratory biomarker study) 1. Patients enrolled in Study A-1. 2. Patients with a peripheral blood eosinophil count of at least 1500 cells per microliter. 3. Patients who have not yet received standard treatment for the underlying disease. 4. Patients aged 20 years or older at the time of informed consent. 5. Patients who provide separate written informed consent, including consent for blood and urine sample collection. Key exclusion criteria - Study A-1 and Study B 1. Patients who do not provide written informed consent. 2. Patients considered unsuitable for participation by the principal investigator or study investigators.

Study A-2 1. Patients with substantial missing clinical data that preclude appropriate analysis. 2. Patients considered unsuitable for inclusion by the principal investigator. Target Size - 1500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 10 Day Anticipated trial start date - 2026 Year 12 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072517

Disclaimer: Curated by HT Syndication.