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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043025
Receipt No. R000049117
Scientific Title Acute exacerbation of fibrosing interstitial lung disease; multicenter retrospective cohort study
Date of disclosure of the study information 2021/01/16
Last modified on 2021/01/15

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Basic information
Public title Acute exacerbation of fibrosing interstitial lung disease; multicenter retrospective cohort study
Acronym Cohort study of acute exacerbation of fibrosing interstitial lung disease
Scientific Title Acute exacerbation of fibrosing interstitial lung disease; multicenter retrospective cohort study
Scientific Title:Acronym Cohort study of acute exacerbation of fibrosing interstitial lung disease
Region
Japan

Condition
Condition Acute exacerbation of fibrosing interstitial lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the course of treatment of fibrosing interstitial lung disease.
Basic objectives2 Others
Basic objectives -Others To improve treatment by assessing patient background and treatment progress.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the clinical course of fibrosing interstitial lung disease.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases treated for acute exacerbation of fibrosing interstitial lung disease between January 2012 and December 2019.
Key exclusion criteria Cases in which the subject himself/herself has requested the refusal of the provision of information
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Daichi
Middle name
Last name Fujimoto
Organization Wakayama Medical University
Division name Department of Pulmonary Medicine and Medical Oncology
Zip code 641-8509
Address 811-1, Kimiidera, Wakayama City
TEL 073-441-0619
Email daichi@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Katsuyuki
Middle name
Last name Furuta
Organization Wakayama Medical University
Division name Department of Pulmonary Medicine and Medical Oncology
Zip code 641-8509
Address 811-1, Kimiidera, Wakayama City
TEL 073-441-0619
Homepage URL
Email k-furuta@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization None
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 Research Ethics Committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama, Wakayama Prefecture
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 神戸市立医療センター中央市民病院(兵庫県)、和歌山県立医科大学附属病院(和歌山県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 16 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 384
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 No longer recruiting
Date of protocol fixation
2020 Year 06 Month 16 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 07 Month 22 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clarify the clinical course by assessing information before diagnosis and at the time of diagnosis of acute exacerbation (patient background, blood tests, respiratory function tests, imaging tests, reasons for exacerbation, treatment for exacerbation, outcome, etc.).

Management information
Registered date
2021 Year 01 Month 15 Day
Last modified on
2021 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049117

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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