UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062890 |
|---|---|
| Receipt number | R000072010 |
| Scientific Title | Biomarker research on interstitial pneumonia using stored serum |
| Date of disclosure of the study information | 2026/09/11 |
| Last modified on | 2026/09/11 18:55:37 |
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Basic information
Public title
Biomarker research on interstitial pneumonia using stored serum
Acronym
Biomarker research on interstitial pneumonia using stored serum
Scientific Title
Biomarker research on interstitial pneumonia using stored serum
Scientific Title:Acronym
Biomarker research on interstitial pneumonia using stored serum
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively investigate whether measuring the candidate biomarker is useful in predicting the diagnosis of the DAD pattern in patients diagnosed with various interstitial pneumonias, including those with the DAD pattern, as well as infections that pose a diagnostic challenge to distinguish from interstitial pneumonia, congestive heart failure, carcinomatous lymphangitis, and acute respiratory distress syndrome. Furthermore, based on the obtained biomarker results, we aim to utilize them in the development of diagnostic reagents for interstitial pneumonia by Tosoh Corporation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic predictive ability of DAD-type interstitial pneumonia based on SFN measurements (sensitivity, specificity, agreement rate, AUC)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 or older who meet any of the following criteria and do not meet any of the exclusion criteria:
1. Individuals diagnosed with interstitial pneumonia
2. Individuals diagnosed with respiratory infections
3. Individuals diagnosed with congestive heart failure
4. Individuals diagnosed with carcinomatous lymphangitis
5. Individuals diagnosed with acute respiratory distress syndrome
Key exclusion criteria
1. Individuals who show neither new shadows nor exacerbation of existing shadows on chest imaging.
2. Individuals who do not undergo blood tests during hospitalization.
3. Individuals who do not show any worsening of their condition, such as requiring hospitalization for diagnostic tests.
4. Individuals who do not undergo chest CT scans during their stay.
5. Individuals who do not have the necessary residual serum.
6. Individuals who cannot secure the required amount of residual serum.
7. Individuals whom the principal investigator deems unsuitable as subjects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hanaoka |
Organization
Shinshu University
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2631
masayuki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhito |
| Middle name | |
| Last name | Ushiki |
Organization
Shinshu University
Division name
First Department of Internal Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2631
Homepage URL
atsuhito@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Tosoh Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Biological and Medical Research Ethics Committee
Address
3-1-1,Asahi, Matsumoto, Japan
Tel
0263-37-3099
mdrinri@shinshu-u.ac.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 | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 11 | 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
Prospective observational study
Management information
Registered date
| 2026 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072010
