UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019092 |
|---|---|
| Receipt number | R000022075 |
| Scientific Title | Prediction of lung function decline in chronic eosinophilic pneumonia |
| Date of disclosure of the study information | 2015/09/22 |
| Last modified on | 2016/09/22 09:35:57 |
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Basic information
Public title
Prediction of lung function decline in chronic eosinophilic pneumonia
Acronym
Prediction of lung function decline in CEP
Scientific Title
Prediction of lung function decline in chronic eosinophilic pneumonia
Scientific Title:Acronym
Prediction of lung function decline in CEP
Region
| Japan |
Condition
Condition
Chronic eosinophilic pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prediction of lung function decline in chronic eosinophlic pneumonia
Basic objectives2
Others
Basic objectives -Others
Assessment of long-term outcome in chronic eosinophlic pneumonia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CLINICAL OUTCOME, PULMONARY FUNCTION TEST
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic eosinophlic pneumonia
Key exclusion criteria
Allergic bronchial pulmonary aspergilosis, eosinophilic granulomatosis with polyangiitis
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKAFUMI SUDA |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan
TEL
053-435-2263
yuzosuzu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUZO SUZUKI |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan
TEL
053-435-2263
Homepage URL
yuzosuzu@hama-med.ac.jp
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant in aid for scientific research
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
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
浜松医科大学第二内科（静岡県）、国立病院機構天竜病院（静岡県）、聖隷三方原病院（静岡県）、磐田市立総合病院（静岡県）、聖隷浜松病院（静岡県）、浜松労災病院（静岡県）、遠州病院（静岡県）、藤枝市立総合病院（静岡県）、静岡市立静岡病院（静岡県）、静岡市立清水病院（静岡県）、静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 22 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: multicenter cohort study
Objective:Patients with chronic eosinophilic pneumonia, diagnosed at our institute between Jan 2000 to Sep 2015.
Measurements:Recurrence, treatments, and pulmonary function tests
Management information
Registered date
| 2015 | Year | 09 | Month | 22 | Day |
Last modified on
| 2016 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022075
