UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022821 |
|---|---|
| Receipt number | R000026297 |
| Scientific Title | Prospective observational study of acute exacerbation of chronic fibrosing interstitial pneumonia |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2023/07/25 09:33:08 |
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Basic information
Public title
Prospective observational study of acute exacerbation of chronic fibrosing interstitial pneumonia
Acronym
AE-fIP regisrty
Scientific Title
Prospective observational study of acute exacerbation of chronic fibrosing interstitial pneumonia
Scientific Title:Acronym
AE-fIP regisrty
Region
| Japan |
Condition
Condition
Acute exacerbation of chronic fibrosing interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical features and prognosis in patients with acute exacerbation of chronic fibrosing interstitial pneumonia
Basic objectives2
Others
Basic objectives -Others
to explore prognostic factors for acute exacerbation of chronic fibrosing interstitial pneumonia
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
60-day mortality and in-hospital mortality
Key secondary outcomes
1.imaging
2.Prognosis
3.Prognostic factor
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Previous or concurrent diagnosis of chronic fibrosing interstiital pneumonia
2.Acute worsening or development of dyspnea typically of less than one month duration
3.Computed tomography with new bilateral ground-glass opacity and/or consolidation
superimposed on a background pattern consistent with fibrosing interstitial pneumonia
4.Deterioration not fully explained by cardiac failure or fluid overload
Key exclusion criteria
1.Patients with malignancy
2.Patients who is judged as an inappropriate case
3. Patients with collagenvascular diseases related fiborosing interstitial pneumonia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kodai Kawamura |
Organization
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Division name
Division of respiratoy medicine
Zip code
Address
5-3-1 Chikami, Kumamoto, Kumamoto 861-4193
TEL
+81-96-351-8000
kodai.kawamura@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kodai Kawamura |
Organization
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Division name
Division of respiratoy medicine
Zip code
Address
5-3-1 Chikami, Kumamoto, Kumamoto 861-4193
TEL
+81-96-351-8000
Homepage URL
kodai.kawamura@gmail.com
Sponsor or person
Institute
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
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
Address
Tel
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
| 2016 | Year | 07 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
July 2016-June 2020
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026297
