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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041052
Receipt No. 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 2020/07/09

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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 450

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
Email 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
Email takashi.hirama.b5@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
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
Email 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)
獨協医科大学(栃木県)
千葉大学(千葉県)
東京大学(東京都)
大阪大学(大阪府)
京都大学(京都府)
岡山大学(岡山大学)
福岡大学(福岡県)
長崎大学(長崎県)

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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2027 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
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046880

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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