UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061370 |
|---|---|
| Receipt number | R000070218 |
| Scientific Title | Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in Northern Nagano Prefecture Region |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2026/04/24 14:56:34 |
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Basic information
Public title
Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in Northern Nagano Prefecture Region
Acronym
Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in the Northern Nagano Prefecture Region
Scientific Title
Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in Northern Nagano Prefecture Region
Scientific Title:Acronym
Identification of Fungi Antigen in Occupational and Residential Hypersensitivity Pneumonitis in the Northern Nagano Prefecture Region
Region
| Japan |
Condition
Condition
Hypersensitivity Pneumonitis
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Patients diagnosed with hypersensitivity pneumonitis at Hokushin General Hospital between March 1,2026 and March 31, 2029, who do not meet any of the exclusion criteria listed below, will be enrolled in this study. Causative fungi will be isolated and identified from the patients living environments. The presence of serum-specific antibodies against the identified fungi will be evaluated using the Ouchterlony method.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In patients with occupational- and residential-related hypersensitivity pneumonitis 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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | SHIRAI |
Organization
Hokushin General Hospital
Division name
Department of Pulmonary Medicine
Zip code
3838505
Address
Nishi 1-5-63, Nakano City, Nagano Prefecture, Japan
TEL
0269222151
tshipulm@hokushin-hosp.jp
Public contact
Name of contact person
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | SHIRAI |
Organization
Hokushin General Hospital
Division name
Department of Pulmonary Medicine
Zip code
3838505
Address
Nishi 1-5-63, Nakano City, Nagano Prefecture, Japan
TEL
0269222151
Homepage URL
tshipulm@hokushin-hosp.jp
Sponsor or person
Institute
Hokushin General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokushin General Hospital
Address
Nishi 1-5-63, Nakano City, Nagano Prefecture, Japan
Tel
0269222151
tshipulm@hokushin-hosp.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070218
