UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038338 |
|---|---|
| Receipt number | R000043693 |
| Scientific Title | Prognostic significance of reserved liver function in recurrent hepatocellular carcinoma after primary hepatectomy |
| Date of disclosure of the study information | 2019/10/19 |
| Last modified on | 2019/10/19 10:06:53 |
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Basic information
Public title
Prognostic significance of reserved liver function in recurrent hepatocellular carcinoma after primary hepatectomy
Acronym
Prognostic significance of reserved liver function in recurrent hepatocellular carcinoma after primary hepatectomy
Scientific Title
Prognostic significance of reserved liver function in recurrent hepatocellular carcinoma after primary hepatectomy
Scientific Title:Acronym
Prognostic significance of reserved liver function in recurrent hepatocellular carcinoma after primary hepatectomy
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated the Child-Pugh-related parameters aiming to reveal the prognostic significance of them in the patients with recurrent HCC.
Basic objectives2
Others
Basic objectives -Others
A retrospective study to investigate post-recurrent prognosis of HCC
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival after recurrence of HCC
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
Patients who underwent a radical hepatectomy for primary HCC and had intrahepatic recurrences.
Key exclusion criteria
Patients who had extrahepatic recurrences.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Saito |
Organization
University of Yamanashi
Division name
First Department of Surgery, Faculty of Medicine
Zip code
409-3898
Address
1110 Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-7390
rsaitoh@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Saito |
Organization
University of Yamanashi
Division name
First Department of Surgery, Faculty of Medicine
Zip code
409-3898
Address
1110 Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-7390
Homepage URL
rsaitoh@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
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
University of Yamanashi
Address
1110 Shimokato, Chuo, Yamanashi, Japan
Tel
055-273-7390
rsaitoh@yamanashi.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
| 2019 | Year | 10 | Month | 19 | 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
106
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective observational study using datasets collected from medical records and clinical database.
Management information
Registered date
| 2019 | Year | 10 | Month | 19 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043693
