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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028192
Receipt No. R000032199
Scientific Title Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions
Date of disclosure of the study information 2017/07/15
Last modified on 2017/07/11

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Basic information
Public title Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions
Acronym Development of integrated database with clinical, radiological and pathological data of IIPs
Scientific Title Development of integrated database with clinical, radiological and pathological data of idiopatihc interstitial pneumonias (IIPs) for multidisciplinary discussions
Scientific Title:Acronym Development of integrated database with clinical, radiological and pathological data of IIPs
Region
Japan

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

Objectives
Narrative objectives1 To develop database system integrating clinical, radiological and pathological data of IIPs and investigate clinical manifestation of IIPs
Basic objectives2 Others
Basic objectives -Others To perform multidisciplinary discussions and investigate clinical manifestation of IIPs
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To develop database system integrating clinical, radiological and pathological data of IIPs
Key secondary outcomes To perform multidisciplinary discussions (MDD) and investigate clinical manifestation of IIPs based on MDD diagnosis.

Base
Study type Others,meta-analysis etc

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 patients diagnosed as having idiopatihc interstitial pneumonias who underwent chest high-resolution computed tomography (HRCT) and surgical lung biopsy
Key exclusion criteria The patients who diagnosed as having other pulmonary disease
Target sample size 500

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, 431-3192 Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Fujisawa
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL 053-435-2263
Homepage URL
Email fujisawa@hama-med.ac.jp

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

Funding Source
Organization Japan Agency for Medical Research and Development
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
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
2017 Year 07 Month 15 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects were patients diagnosed as having IIPs with surgical lung biopsy. Clinical data, HRCT images and lung histological specimens were collected retrospectively, and develop integrated database including clinical, radiological and pathological data.
Multidisciplinary discussions (MDD) were performed by a clinician, radiologist, and pathologist to get final diagnoses using the database.
Clinical manifestation were analyzed in each disease based on MDD diagnosis.

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032199

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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