UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040396 |
|---|---|
| Receipt number | R000046096 |
| Scientific Title | A prospective observational study for surveying the practice patterns in rare respiratory diseases |
| Date of disclosure of the study information | 2020/05/14 |
| Last modified on | 2025/05/19 08:36:08 |
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Basic information
Public title
A prospective observational study for surveying the practice patterns in rare respiratory diseases
Acronym
CS-Lung Rare
Scientific Title
A prospective observational study for surveying the practice patterns in rare respiratory diseases
Scientific Title:Acronym
CS-Lung Rare
Region
| Japan |
Condition
Condition
Rare respiratory diseases
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the real-world practice patterns for patients with rare respiratory diseases in NPO CS-Lung
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of first-line treatment in each disease
Key secondary outcomes
All practice patterns including diagnostic methods and survival data
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with rare respiratory diseases such as empyema necessary to drainage, pulmonary Langerhans cell histiocytosis, pleuroparenchymal fibroelastosis, pulmonary alveolar proteinosis, and progressive fibrosing interstitial lung diseases
Key exclusion criteria
Patients without written informed concent
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Kanaji |
Organization
Kagawa University
Division name
Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine, Faculty of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2145
kanaji@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Kanaji |
Organization
Kagawa University
Division name
Department of Internal Medicine, Division of Hematology, Rheumatology and Respiratory Medicine
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
087-891-2145
Homepage URL
kanaji@med.kagawa-u.ac.jp
Sponsor or person
Institute
NPO CS-Lung
Institute
Department
Personal name
Funding Source
Organization
NPO CS-Lung
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
087-898-5111
kenkyushien@med.kagawa-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
| 2020 | Year | 05 | Month | 14 | 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
| 2020 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in progress
Management information
Registered date
| 2020 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046096
