UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044825 |
|---|---|
| Receipt number | R000051199 |
| Scientific Title | Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia. |
| Date of disclosure of the study information | 2021/09/08 |
| Last modified on | 2022/10/05 15:57:29 |
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Basic information
Public title
Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Acronym
Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Scientific Title
Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Scientific Title:Acronym
Detection of novel biomarkers in patients with interstitial pneumonia or acute exacerbation of interstitial pneumonia.
Region
| Japan |
Condition
Condition
Patients with interstitial pneumonias or acute exacerbation of interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate novel biomarkers for the diagnostic and prognostic significance in patients with interstitial pneumonias or acute exacerbation of interstitial pneumonias.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Diagnostic capacity, percent predicted forced vital capacity (%FVC) and diffusion lung capacity for carbon monoxide (%DLCO), the partial pressure of arterial oxygen (PaO2) at rest and minimum partial oxygen saturation during the 6-min walk test (6MWT), serum KL-6/SP-D, HRCT findings, findings on lung specimens, response to treatments
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients, who were diagnosed as interstitial pneumonias (IPs) or acute exacerbation of interstitial pneumonias from 1980, and whose serum were available, were included. IPs were diagnosed based on the presence of chest fine crackles, high-resolution computed tomography findings, and preexisting biomarkers.
The diagnosis of acute exacerbation of IPs were based on diagnostic criteria for acute exacerbation of idiopathic pulmonary fibrosis (Collard H et al. AJRCCM 2016).
Key exclusion criteria
Patients with severe heart failure or excessive fluid overload were excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu
TEL
+81-53-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Enomoto |
Organization
Hamamatsu University School of Medicine
Division name
Health administration center
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu
TEL
+81-53-435-2263
Homepage URL
norieno@hama-med.ac.p
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu
Tel
+81-53-435-2263
+81-53-435-2263
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
| 2021 | Year | 09 | Month | 08 | 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
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 07 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051199
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
