UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027539 |
|---|---|
| Receipt number | R000031443 |
| Scientific Title | Automatic 3D-construction of hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/05/30 |
| Last modified on | 2022/12/03 10:14:48 |
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Basic information
Public title
Automatic 3D-construction of hepatocellular carcinoma
Acronym
3D-HCC
Scientific Title
Automatic 3D-construction of hepatocellular carcinoma
Scientific Title:Acronym
3D-HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To construct 3D-HCC images automatically, we developed a new computer program, and we investigated the validity of the program by comparing the developed images with those of resection specimens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The similarities between a cut-surface of 3D-HCC and a real cut-surface images of resected 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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as overt HCC by enhanced CT and had liver resection.
Key exclusion criteria
Patients with allergy of contrast material. Patients with no indication of surgery.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
1738610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
nakayama.hisashi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Nakayama |
Organization
Nihon University School of Medicine
Division name
Department of Digestive Surgery
Zip code
1738610
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
Homepage URL
nakayama.hisashi@nihon-u.ac.jp
Sponsor or person
Institute
Department of Digestive Surgery, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Digestive Surgery, Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Nihon University School of Medicine
Address
30-1 Oyaguchikami-cho, Itabashi-ku, Tokyo 173-8610, Japan
Tel
0339728111
med.itabashi.chiken@nihon-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
日本大学医学部消化器外科(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000031443&t
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000031443&t
Number of participants that the trial has enrolled
300
Results
under observation
Results date posted
| 2022 | Year | 12 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Requires detailed follow-up
Date of the first journal publication of results
Baseline Characteristics
Liver cancer patients scheduled for hepatectomy
Participant flow
Blood sampling and imaging every 3 months
Adverse events
no
Outcome measures
Ongoing follow-up
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Accumulation of examination data, and analysis are ongoing.
Management information
Registered date
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2022 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031443
| 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 |
