UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040245 |
|---|---|
| Receipt number | 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 | 2022/05/01 23:10:30 |
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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
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
ktaura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
