UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033823 |
|---|---|
| Receipt number | R000038578 |
| Scientific Title | Multimodal treatment of HCC, Bile duct cancer and metastatic liver cancer: a multi-institutional retrospective study |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2020/08/25 12:21:03 |
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Basic information
Public title
Multimodal treatment of HCC, Bile duct cancer and metastatic liver cancer: a multi-institutional retrospective study
Acronym
Multimodal treatment of HCC, Bile duct cancer and metastatic liver cancer: a multi-institutional retrospective study
Scientific Title
Multimodal treatment of HCC, Bile duct cancer and metastatic liver cancer: a multi-institutional retrospective study
Scientific Title:Acronym
Multimodal treatment of HCC, Bile duct cancer and metastatic liver cancer: a multi-institutional retrospective study
Region
| Japan | Asia(except Japan) | North America |
| Australia | Europe |
Condition
Condition
Hepatocellular carcinoma, intrahepatic cholangiocarcinoma, neuroendocrine or colorectal liver metastases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study will assess the relationship between preoperative evaluation, tumor markers, clinicopathologic data, operative strategies, and short- and long-term outcomes of patients with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, neuroendocrine and colorectal liver metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
long-term outcomes of patients from multimodal treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Surgical resection for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, colorectal liver metastases, or neuroendocrine liver metastases
Key exclusion criteria
No pathologic confirmation of tumor
Age <18 years
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Endo |
Organization
Yokohama City University Hospital
Division name
Gastoenterological Surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
045-787-2800
endoit@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sahara |
Organization
Yokohama City University Hospital
Division name
Gastoenterological Surgery
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
045-787-2800
Homepage URL
s.kota90@gmail.com
Sponsor or person
Institute
Yokohama City University Hospital, Department of Gastoenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
Tel
045-787-2800
s.kota90@gmail.com
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
| 2018 | Year | 10 | 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
1829
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
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038578
| 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 |
