UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055890 |
|---|---|
| Receipt number | R000063872 |
| Scientific Title | Landscape of patients with hepatocellular carcinoma who eventuated in interventional failure or non-curative recurrence following liver resection |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2025/10/21 09:39:52 |
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Basic information
Public title
Landscape of patients with hepatocellular carcinoma who eventuated in interventional failure or non-curative recurrence following liver resection
Acronym
Non-curative recurrence of HCC
Scientific Title
Landscape of patients with hepatocellular carcinoma who eventuated in interventional failure or non-curative recurrence following liver resection
Scientific Title:Acronym
Non-curative recurrence of HCC
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our study aimed to explore the clinical significance of postoperative non-curative recurrence.
Basic objectives2
Others
Basic objectives -Others
Survival after non-curative recurrence
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concordance index between the respective overall survival, recurrence-free survival and time to surgical failure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Initial hepatectomy for HCC
Key exclusion criteria
R2 resection
Target sample size
266
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University
Division name
Department of Hepato-biliary and Pancreatic Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
a-saiura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takeda |
| Middle name | |
| Last name | Yoshinori |
Organization
Juntendo University
Division name
Department of Hepato-biliary and Pancreatic Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
yo-takeda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee, Faculty of Medicine, Juntendo University
Address
2-1-1, Hongo, Bunkyo, Tokyo
Tel
03-3813-3111
igakubu.rinri1@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 21 | 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
266
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063872
