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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003399
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Sapporo medical university
Third department of internal medicine
Institute
Department

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
Email

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
URL(English) https://upload.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


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