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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014806
Receipt No. R000017199
Scientific Title Multicenter prospective study evaluating the long term outcome after medical treatment for primary hepatocellular carcinoma
Date of disclosure of the study information 2014/08/09
Last modified on 2019/08/13

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Basic information
Public title Multicenter prospective study evaluating the long term outcome after medical treatment for primary hepatocellular carcinoma
Acronym Multicenter prospective study evaluating the long term outcome after medical treatment for primary hepatocellular carcinoma
Scientific Title Multicenter prospective study evaluating the long term outcome after medical treatment for primary hepatocellular carcinoma
Scientific Title:Acronym Multicenter prospective study evaluating the long term outcome after medical treatment for primary hepatocellular carcinoma
Region
Japan

Condition
Condition Primary hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of medical treatment for primary hepatocellular carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Recurrence-free survival
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 Untreated primary hepatocellular carcinoma
Key exclusion criteria Patients whom the physicians in charge judge their enrollment inappropriate.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81-6-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ryotaro
Middle name
Last name Sakamori
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 5650871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81-6-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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 Medical Center for Translational and Clinical Research, Osaka University Hospital
Address 2-2 Yamadaoka, Suita, Osaka, Japan
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 09 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 18 Day
Date of IRB
2013 Year 07 Month 18 Day
Anticipated trial start date
2014 Year 07 Month 18 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective study for primary hepatocellular carcinoma.
The efficacy and long-term outocmes will be evaluated.

Management information
Registered date
2014 Year 08 Month 09 Day
Last modified on
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017199

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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