UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1118
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	Main results already published
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	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045913