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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040396
Receipt No. 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 2020/05/14

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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
Email 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
Email kanaji@med.kagawa-u.ac.jp

Sponsor
Institute NPO CS-Lung
Institute
Department

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
Email mdkenshi1@jim.ao.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
2020 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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