UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027844 |
|---|---|
| Receipt number | R000031899 |
| Scientific Title | Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2020/06/13 16:54:36 |
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Basic information
Public title
Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Acronym
Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Scientific Title
Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Scientific Title:Acronym
Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Region
| Japan |
Condition
Condition
acute deterioration of interstitial lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between prognosis and clinical factors in interstitial lung diseases after the deterioration of dyspnea with new pulmonary shadows
Basic objectives2
Others
Basic objectives -Others
To make new diagnostic criteria of acute exacerbation of interstitial lung diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical factors to determine 3-month survival of acute deterioration in interstitial lung diseases
Key secondary outcomes
1)Clinical factors to determine 1-year survival of acute deterioration in interstitial lung diseases
2)Change of clinical parameters after acute deterioration of ILDs
3)Therapy
4)Cause of death
5)Adverse events
6)Efficacy of present diagnostic criteria of acute exacerbation
7)Comparison of present diagnostic criterion of acute exacerbation
8)To make a new diagnostic criteria of acute exacerbation of ILDs
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) idiopathic interstitial pneumonias (IIPs) and interstitial lung diseases (ILDs) other than IIPs including chronic hypersensitivity pneumonia, collagen vascular diseases-ILDs and asbestosis
2) Cases that deteriorated with deterioration of dyspnea and newly developed pulmonary shadows.
Key exclusion criteria
1) Survival is supposed to be less than 3 months due to complications of ILDs
2) Cases that researchers have determined to be improper for inclusion
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Arai |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
arai.toru.cp@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsui |
Organization
NHO Kinki-Chuo Chest Medical Center
Division name
Clinical Research Center
Zip code
591-8555
Address
1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL
072-252-3021
Homepage URL
matsui.yuki.yx@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kinki-Chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review board of NHO Kinki-Chuo Chest Medical Center
Address
1180 Nagasone-Cho, Kita-Ku, Sakai Osaka, Japan
Tel
072-252-3021
agata.yuka.zd@mail.hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
H28-NHO(Kokyu)-02
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | 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
416
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
| 2016 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 09 | 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
Birth month, gender, past history, complications, smoking status, height, weight, physical examination, radiological findings, laboratory findings, therapy, clinical course, outcome, last follow-up date
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031899
