UMIN-CTR Clinical Trial

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 Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
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 Tomoyuki Middle name Last name Fujisawa
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Zip code	431-3192
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
Tel	053-435-2972
Email	rinri@hama-med.ac.jp

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	Completed
Date of protocol fixation	2017 Year 02 Month 10 Day
Date of IRB	2017 Year 05 Month 31 Day
Anticipated trial start date	2017 Year 07 Month 12 Day
Last follow-up date	2021 Year 12 Month 31 Day
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	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032199