Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061370) titled 'Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in Northern Nagano Prefecture Region' on April 30.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Hokushin General Hospital
Condition:
Condition - Hypersensitivity Pneumonitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Hypersensitivity pneumonitis (HP) is an allergic lung disease caused by repeated inhalation of causative antigens. A wide variety of organic and inorganic dusts can serve as causative antigens. Fungi are among the most common causative antigens of HP, and multiple fungal species, including Aspergillus and Penicillium, have been implicated.
The aim of this study is to identify the fungi responsible for HP in the northern Nagano region. We will enroll patients with occupational- and residential-related HP in whom environmental fungi are suspected to be the causative antigens. Fungi will be isolated and identified from workplace and residential exposure environments, and the presence of serum-specific antibodies against the identified fungi will be evaluated.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - During routine blood sampling (venous blood collection), 10 mL of blood for serum biochemical analysis (one 10-mL collection tube) will be obtained. The presence of specific antibodies in patient serum against fungi isolated from the environment will be determined by the presence or absence of precipitation lines using the Ouchterlony method.
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with hypersensitivity pneumonitis at Hokushin General Hospital between March 1, 2026 and March 31, 2029, who do not meet any of the following exclusion criteria, will be enrolled in this study.
Key exclusion criteria - Individuals under 20 years of age
Patients deemed unsuitable for participation in the study by the principal investigator or study investigators
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 27 Day
Date of IRB - 2026 Year 04 Month 27 Day
Anticipated trial start date - 2026 Year 05 Month 01 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=R000070218
Disclaimer: Curated by HT Syndication.