UMIN-CTR Clinical Trial

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