UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053872 |
|---|---|
| Receipt number | R000061497 |
| Scientific Title | Biomarker research related to interstitial pneumonia |
| Date of disclosure of the study information | 2024/03/15 |
| Last modified on | 2024/03/15 14:13:02 |
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Basic information
Public title
Biomarker research related to interstitial pneumonia
Acronym
Biomarker research related to interstitial pneumonia
Scientific Title
Biomarker research related to interstitial pneumonia
Scientific Title:Acronym
Biomarker research related to interstitial pneumonia
Region
| Japan |
Condition
Condition
interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study prospectively examines whether measurement of biomarker candidates is useful for early detection of interstitial pneumonia and diagnosis and prediction of diffuse alveolar damage pattern in patients suspected of having interstitial pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate between diagnostic prediction results based on biomarker values and final clinical diagnosis information
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have an acute or subacute course of deterioration in respiratory status or new respiratory symptoms, and who have new lung shadows observed on imaging tests and who may have interstitial pneumonia.
Key exclusion criteria
Persons judged by the research director to be unsuitable as subjects
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hanaoka |
Organization
Shinshu University School of Medicine
Division name
First Department of Internalmedicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, 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 School of Medicine
Division name
First Department of Intenal Medicine
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2531
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
the medical ethics committee of Shinshu University School of Medicine
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
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
| 2024 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 06 | 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
Observation items
Gender, age, height, weight, medical history.
Subjective and objective symptoms: body temperature, appearance of respiratory symptoms, cough, shortness of breath, respiratory rate, SpO2, chest auscultation findings.
Imaging findings, blood tests, bronchoalveolar lavage tests, sputum tests, histopathological tests, and echocardiography.
Final diagnosis result.
Treatment and outcome.
Primary disease, drug history.
Management information
Registered date
| 2024 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061497
