UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041831 |
|---|---|
| Receipt number | R000047756 |
| Scientific Title | Predictors of mortality in patients with acute exacerbations of chronic interstitial lung disease: a retrospective cohort study |
| Date of disclosure of the study information | 2020/09/18 |
| Last modified on | 2023/03/21 09:50:49 |
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Basic information
Public title
Predictors of mortality in patients with acute exacerbations of chronic interstitial lung disease: a retrospective cohort study.
Acronym
Predictors of mortality in patients with acute exacerbations of interstitial lung disease: a retrospective cohort study
Scientific Title
Predictors of mortality in patients with acute exacerbations of chronic interstitial lung disease: a retrospective cohort study
Scientific Title:Acronym
Cohort study of acute exacerbation of ILD
Region
| Japan |
Condition
Condition
Acute exacerbation of chronic interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To predict of mortality in patients with acute exacerbations of chronic interstitial lung disease
Basic objectives2
Others
Basic objectives -Others
To create a predictive score
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm the predictors of mortality in patients with acute exacerbations of chronic interstitial lung disease
Key secondary outcomes
To determine whether an overall HRCT score could be helpful in predicting of mortality in patients with acute exacerbations of chronic interstitial lung disease
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as acute exacerbation of chronic interstitial lung disease between 2009 and 2017.
Key exclusion criteria
Cases with unknown outcome 3 months after diagnosis
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Kondoh |
Organization
Tosei Gneral Hospital
Division name
Respiratory Medicine and Allergy
Zip code
489-8642
Address
160 Nishioiwake-cho, Seto, Aichi
TEL
+81-561-82-5101
konyasu2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Kataoka |
Organization
Tosei Gneral Hospital
Division name
Respiratory Medicine and Allergy
Zip code
489-8642
Address
160 Nishioiwake-cho, Seto, Aichi
TEL
0561-82-5101
Homepage URL
kataoka@tosei.or.jp
Sponsor or person
Institute
the Diffuse Lung Diseases Research Group from the Ministry of Health, Labor and Welfare, Japan
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
Tosei General Hospital IRB
Address
160 Nishioiwake-cho, Seto, Aichi
Tel
0561-82-5101
ychiken@tosei.or.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
国立国際医療研究センター（東京都）、神戸市立医療センター中央市民病院（兵庫県）、神戸市立医療センター西市民病院（兵庫県）、神奈川県立循環器呼吸器病センター（神奈川県）、倉敷中央病院（岡山県）、東京医科歯科大学医学部附属病院（東京都）、浜松医科大学医学部附属病院（静岡県）、名古屋大学医学部附属病院（愛知県）、自治医科大学附属病院（埼玉県）、近畿大学医学部附属病院（大阪府）、虎の門病院（東京都）、沖縄県立中部病院（沖縄県）、済生会熊本病院（熊本県）、天理よろづ相談所病院（奈良県）、東邦大学医療センター大森病院（東京都）、順天堂大学順天堂医院（東京都）、公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 18 | 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
1000
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing for paper submission
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
| 2019 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Parameters to evaluate
Data at diagnosis (patient characteristics, disease stage, vital sign, laboratory data, oxygenation, high resolution CT)
Treatment
Respiratory management
Create a risk sore that predicts 3-months mortality
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047756
| Research Plan | |
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| 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 |
