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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040245
Receipt No. R000045913
Scientific Title Impact of donor sex on the outcomes of liver transplantation for hepatocellular carcinoma
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27

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Basic information
Public title Impact of donor sex on the outcomes of liver transplantation for hepatocellular carcinoma
Acronym donor sex and the outcomes of liver transplantation for hepatocellular carcinoma
Scientific Title Impact of donor sex on the outcomes of liver transplantation for hepatocellular carcinoma
Scientific Title:Acronym donor sex and the outcomes of liver transplantation for hepatocellular carcinoma
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify the impact of donor sex on the outcomes of liver transplantation for hepatocellular carcinoma
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence rate of hepatocellular carcinoma
Key secondary outcomes overall survival rate
disease-specific survival rate
recurrence-free survival rate

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 Patients with hepatocellular carcinoma who underwent liver transplantation in Japan between 1990/1/1~2017/12/31
Key exclusion criteria Cases with missing values in the essential items (presence or absence of recurrence, number of days until recurrence, and donor sex) that are indispensable for evaluating the impact of donor sex on the primary endpoint (recurrence of hepatocellular carcinoma)
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kojiro
Middle name
Last name Taura
Organization Kyoto University Graduate School of Medicine
Division name Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplantation)
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto
TEL +81-75-751-3242
Email ktaura@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Kojiro
Middle name
Last name Taura
Organization Kyoto University Graduate School of Medicine
Division name Department of Surgery (Division of Hepato-Biliary-Pancreatic Surgery and Transplantation)
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto
TEL +81-75-751-3242
Homepage URL
Email ktaura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Self funding
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, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto-city
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 京都大学大学院医学研究科
日本肝移植学会

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 27 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 04 Month 27 Day
Date of IRB
2020 Year 04 Month 27 Day
Anticipated trial start date
2020 Year 04 Month 27 Day
Last follow-up date
2023 Year 04 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective analysis of the data of Japanese Liver Transplantation Society

Management information
Registered date
2020 Year 04 Month 27 Day
Last modified on
2020 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045913

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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