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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010231
Receipt No. R000011953
Scientific Title Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Date of disclosure of the study information 2013/04/01
Last modified on 2017/03/16

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Basic information
Public title Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Acronym IIPs with features similar to CVD
Scientific Title Multiinstitutional prospective study on idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Scientific Title:Acronym IIPs with features similar to CVD
Region
Japan

Condition
Condition Idiopathic interstitial pneumonias
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical course and prognosis in idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Basic objectives2 Others
Basic objectives -Others To evaluate the incidence of idiopathic interstitial pneumonias with features similar to collagen vascular diseases
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival rate
Key secondary outcomes Change in Forced Vital Capacity, Change of lung opacities on High Resolution Computed Tomography

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with idiopathic interstitial pneumonias
Key exclusion criteria Patients who meet the criteria for any collagen vascular diseases
Target sample size 350

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, Higashiku, Hamamatsu, Japan
TEL 81534352263
Email norieno@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Enomoto
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama, Higashiku, Hamamatsu, Japan
TEL 81534352263
Homepage URL
Email norieno@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor, and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2013 Year 04 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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Incidence, response rate to treatments, and prognosis will be observed prospectively in patients with idiopathic interstitial pneumonias with features similar to collagen vascular diseases. Patients with idiopathic interstitial pneumonias will be enrolled consecutively.

Management information
Registered date
2013 Year 03 Month 13 Day
Last modified on
2017 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011953

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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