UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037369 |
|---|---|
| Receipt number | R000042606 |
| Scientific Title | Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2019/07/14 |
| Last modified on | 2019/07/14 11:43:56 |
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Basic information
Public title
Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Acronym
Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Scientific Title
Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Scientific Title:Acronym
Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection 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
to investigate the value of the CONUT plus Tumor Burden (CONUT-TB) score as a prognostic predictor in patients with HCC undergoing liver resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
value of the CONUT plus Tumor Burden (CONUT-TB) score as a prognostic predictor in patients with HCC undergoing liver resection
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
Between January 2015 and December 2018, patients with HCC underwent liver resection at our institution
Key exclusion criteria
Patients undergoing repeated liver resection and combined resection of a metastatic lesion were excluded
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Fukami |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
81-561-62-3311
yasuyuki490225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Fukami |
Organization
Aichi Medical University
Division name
Gastroenterological Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi
TEL
81-561-62-3311
Homepage URL
yasuyuki490225@yahoo.co.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
81-561-62-3311
yasuyuki490225@yahoo.co.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 | 07 | Month | 14 | 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
81
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The median follow-up period after diagnosis was 18 months
Management information
Registered date
| 2019 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042606
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
