UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040604 |
|---|---|
| Receipt number | R000046339 |
| Scientific Title | Verification of Automatic segmentatioN Using Graphical OrganizinG software for 3D Hepatic structures |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2025/03/21 20:27:17 |
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Basic information
Public title
Verification of Automatic segmentatioN
Using Graphical OrganizinG software for 3D Hepatic structures
Acronym
VAN-GOGH Study
Scientific Title
Verification of Automatic segmentatioN
Using Graphical OrganizinG software for 3D Hepatic structures
Scientific Title:Acronym
VAN-GOGH Study
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of automatic segmentation using 3D graphical simulation software for Hepatic structures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volumetric error of a tumor-bearing Couinaud's liver segment between artificial intelligence calculation and manual calculation
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are scheduled of or underwent liver resection for liver tumor
2) Patients who are scheduled of or underwent a one-millimeter thickness slice computed tomography scan
Key exclusion criteria
Patients who do not meet inclusion criteria
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Hepatibilliary Pancreatic Surgery
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuou-ku, Tokyo
TEL
+81-3-3542-2511
ttakamot@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Hepatibilliary Pancreatic Surgery
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuou-ku, Tokyo
TEL
+81-3-3542-2511
Homepage URL
ttakamot@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujifilm Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuou-ku, Tokyo
Tel
+81-3-3542-2511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2019-355
Org. issuing International ID_1
National Cancer Center Hospital IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046339
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046339
Number of participants that the trial has enrolled
100
Results
The validity of the 3D liver structure automatic extraction program was verified.
Results date posted
| 2025 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The validity of the 3D liver structure automatic extraction program was verified.
Participant flow
The validity of the 3D liver structure automatic extraction program was verified.
Adverse events
not particular
Outcome measures
The validity of the 3D liver structure automatic extraction program was verified.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NP
Management information
Registered date
| 2020 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046339
