UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017852 |
|---|---|
| Receipt number | R000020688 |
| Scientific Title | Clinicopathological factors in hepatocellular carcinoma with microscopic portal vein invasion. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2017/03/14 16:08:34 |
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Basic information
Public title
Clinicopathological factors in hepatocellular carcinoma with microscopic portal vein invasion.
Acronym
Clinicopathological factors in HCC with vp1.
Scientific Title
Clinicopathological factors in hepatocellular carcinoma with microscopic portal vein invasion.
Scientific Title:Acronym
Clinicopathological factors in HCC with vp1.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of clinicopathological factors in HCC with vp1
Basic objectives2
Others
Basic objectives -Others
Analysis of clinicopathological factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prognostic factors for survival and recurrence
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
initial hepatectomy for HC with vp1
Key exclusion criteria
exept for initial hepatectomy
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Kamiyama |
Organization
Hokkaido University
Division name
Gastroenterological surgery I
Zip code
Address
N-15, W-7, Kita-Ku, Sapporo
TEL
011-706-5927
t-kamiya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Shimada |
Organization
Hokkaido University
Division name
Gastroenterological surgery I
Zip code
Address
N-15, W-7, Kita-Ku, Sapporo
TEL
011-706-5927
Homepage URL
shingoshimada1979@true.ocn.ne.jp
Sponsor or person
Institute
Department of Gastroenterological surgery I, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological surgery I, Hokkaido University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 1991 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1991 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 14 | Day |
Other
Other related information
Even if no portal venous invasion is detectable in HCC patients preoperatively, a PIVKA-II above 100 mAU/ml, tumor size above 5 cm, and a confluent lesion indicate a high risk of mPVI. ALR should be considered for the patients with these characteristics because it is a favorable prognostic factor in these cases with mPVI.
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020688
| 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 |
