UMIN-CTR Clinical Trial

Basic information
Public title	Clinical, radiological, and pathological study using lungs of pleuroparenchymal fibroelastosis(PPFE)explanted from lung transplant recipients.
Acronym	Clinical, radiological, and pathological study using lungs of pleuroparenchymal fibroelastosis(PPFE)explanted from lung transplant recipients.
Scientific Title	Clinical, radiological, and pathological study using lungs of pleuroparenchymal fibroelastosis(PPFE)explanted from lung transplant recipients.
Scientific Title:Acronym	Clinical, radiological, and pathological study using lungs of pleuroparenchymal fibroelastosis(PPFE)explanted from lung transplant recipients.
Region	Japan

Condition
Condition	interstitial pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate clinical, radiological and pathological characteristics of patients with advanced PPFE.
Basic objectives2	Others
Basic objectives -Others	clinical, radiological and pathological characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference of clinical, radiological and pathological characteristics between idiopathic and secondary PPFE in advanced stage.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patinets with interstitial pneumonia who underwent lung transplantation in Kyoto university during the period between 2010 to 2018.
Key exclusion criteria	1) Patients with active malignancy at the time of transplantation who have not achieved remission 2) Patients whose HRCT images or lung histopathology were unavailable. 3) Patients under 18 years old (because there is no HRCT image) 4) Patients who underwent lung transplantation before 2009 (because there is no HRCT image) 5) Patients who disagreed with enrollment in this study. 6) Patients who are considered inappropriate for enrollment in this study by the principal investigator or research coordinator
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Tomohiro Middle name Last name Handa
Organization	Graduate school of medicine, Kyoto university
Division name	Department of advanced medicine for respiratory failure
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-366-7689
Email	hanta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Handa
Organization	Graduate school of medicine, Kyoto university
Division name	Department of advanced medicine for respiratory failure
Zip code	6068507
Address	54 Kawaharacho Shogoin Sakyo-ku Kyoto
TEL	075-366-7689
Homepage URL
Email	hanta@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto university
Institute
Department

Funding Source
Organization	Kyoto university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto university graduate school and faculty of medicine, ehics committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto , JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.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	2020 Year 06 Month 23 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	2020 Year 03 Month 24 Day
Date of IRB	2020 Year 06 Month 22 Day
Anticipated trial start date	2020 Year 06 Month 23 Day
Last follow-up date	2021 Year 11 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	single center, retrospective, observational study

Management information
Registered date	2020 Year 06 Month 23 Day
Last modified on	2021 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045256