UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041052 |
|---|---|
| Receipt number | R000046880 |
| Scientific Title | Analysis of risk factors for the waiting-list mortality among the lung transplant candidates in Japan |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2024/01/11 12:04:21 |
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Basic information
Public title
Waiting list mortality for lung transplant in Japan
Acronym
Waiting list mortality for lung transplant in Japan
Scientific Title
Analysis of risk factors for the waiting-list mortality among the lung transplant candidates in Japan
Scientific Title:Acronym
Analysis of risk factors for the waiting-list mortality among the lung transplant candidates in Japan
Region
| Japan |
Condition
Condition
lung transplant
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
multi-institutional prospective analysis of risk factors for the waiting-list mortality among lung transplant candidates in Japan
Basic objectives2
Others
Basic objectives -Others
Analysis of risk factors for the waiting-list mortality based on the transplant indication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
deceased-donor transplant, living-donor transplant, withhold, dead
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
| Not applicable |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients newly listed for lung transplant
Key exclusion criteria
Patients from those whom an informed consent was not obtained
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hirama |
Organization
Tohoku University Hospital
Division name
Department of Thoracic Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 98 0-8574 Japan
TEL
0227178521
takashi.hirama.b5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hirama |
Organization
Tohoku University Hospital
Division name
Department of Thoracic Surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 98 0-8574 Japan
TEL
0227178521
Homepage URL
takashi.hirama.b5@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dokkyo Medical University
Chiba University
Tokyo University
Fujita Health University
Osaka University
Kyoto University
Okayama University
Fukuoka University
Nagasaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine, Institutional Review Board committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
0227284105
med-kenkyo@grp.tohoku.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
東北大学（宮城県）、IRB承認 (20200927)
獨協医科大学（栃木県）、IRB承認 (20201124)
千葉大学（千葉県）、IRB承認 (20210406)
東京大学（東京都）、IRB承認 (20210426)
藤田医科大学（愛知県）、IRB承認 (20210727)
大阪大学（大阪府）、IRB承認 (20201221)
京都大学（京都府）、IRB承認 (20201017)
岡山大学（岡山大学）、IRB承認 (20201211)
福岡大学（福岡県）、IRB承認 (20201209)
長崎大学（長崎県）、IRB承認 (20201222)
名古屋大学（愛知県）、IRB承認（20231227）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | 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
| 2020 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study results have not been analyzed
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046880
| Research Plan | |
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| 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 |
