UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040866 |
|---|---|
| Receipt number | R000045256 |
| Scientific Title | Clinical, radiological, and pathological study using lungs of pleuroparenchymal fibroelastosis(PPFE)explanted from lung transplant recipients. |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2021/12/23 16:06:42 |
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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
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
hanta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045256
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
