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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033823
Receipt No. 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 2018/12/18

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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
Middle name
Last name Itaru Endo
Organization Yokohama City University Hospital
Division name Gastoenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL 045-787-2800
Email endoit@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kota Sahara
Organization Yokohama City University Hospital
Division name Gastoenterological Surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL 045-787-2800
Homepage URL
Email s.kota90@gmail.com

Sponsor
Institute Yokohama City University Hospital, Department of Gastoenterological Surgery
Institute
Department

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
Address
Tel
Email

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 Unpublished

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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
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
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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