UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003399 |
|---|---|
| Receipt number | R000004052 |
| Scientific Title | Epidemiological suevey of patients with idiopathic interstitual pneumonias in Hokkaido |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/10/10 09:43:20 |
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Basic information
Public title
Epidemiological suevey of patients with idiopathic interstitual pneumonias in Hokkaido
Acronym
Epidemiological suevey of patients with idiopathic interstitual pneumonias in Hokkaido
Scientific Title
Epidemiological suevey of patients with idiopathic interstitual pneumonias in Hokkaido
Scientific Title:Acronym
Epidemiological suevey of patients with idiopathic interstitual pneumonias in Hokkaido
Region
| Japan |
Condition
Condition
Idiopathic Interstitial Pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The idiopathic interstitial pneumonias(IIPs)are a heterogeneous group of lung diseases characterized by varying degrees ofinflammation and fibrosis. Since the Specific Disease/Pulmonary Fibrosis Survey/Study Group of the Ministry of Health and Welfare(currently,Study Group on Diffuse Pulmonary Disorders,Scientific Research /Refractiry Disease-Overcoming Research Business,
Ministry of Health,Labor and Welfare)
was established in 1974,a clinical personal record of IIPs patient is to be submitted to the local government.Epidemiological survey of idiopathic interstitial pneumonias(IIPs)
in Hokkaido was conducted using these clinical personal records from 2003 to 2007.Unlike other local governments,all disease severity (severity lebel 1 to 4)is accepted In Hokkaido. From such a background, the actual state of IPPs can be understood precisely by this suevey. The objective of this study was to describe the trends in the prognostic factor of IIPs in the community.
Basic objectives2
Others
Basic objectives -Others
The second objective of the study was to investigate the trends in the incidence ,prevalence in the community.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specify the prescribed prognostic factor of IIps
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
The subjects were 605 IIPs cases(102 hospitals)those to whom a certificate of medical benefits was delivered from 2003 to 2007. The qualification of medical benefits for IIPs are prescribed by Ministry of Health,Labor,and Welfare and judged in Hokkaido.
Key exclusion criteria
none
Target sample size
605
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Takanashi |
Organization
Sapporo medical university
Division name
Third department of internal medicine
Zip code
Address
nishi 17 choume minami 1jyo chuo-ku sapporo
TEL
(011)611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Chiba |
Organization
Sapporo medical university
Division name
Third department of internal medicine
Zip code
Address
nishi 17 choume minami 1jyo chuo-ku sapporo
TEL
(011)611-2111
Homepage URL
Sponsor or person
Institute
Sapporo medical university
Third department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
Study group on diffuse pulmonary disorders, scientific research/refractory disease-overcoming research business
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2013 | Year | 07 | Month | 01 | Day |
Other
Other related information
It is a prospective study to specify the prognotic factor of IIPs by doing the living confirmation.
Management information
Registered date
| 2010 | Year | 03 | Month | 29 | Day |
Last modified on
| 2012 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004052
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
