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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001317
Receipt No. R000001604
Scientific Title Identification of aberrant promoter methylation in liver cancer
Date of disclosure of the study information 2008/09/10
Last modified on 2010/08/17

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Basic information
Public title Identification of aberrant promoter methylation in liver cancer
Acronym Identification of aberrant promoter methylation in liver cancer
Scientific Title Identification of aberrant promoter methylation in liver cancer
Scientific Title:Acronym Identification of aberrant promoter methylation in liver cancer
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To identify aberrant DNA methylation in peripheral blood and cancer tissues for early diagnosis of liver cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of aberrant DNA methylation in peripheral blood and cancer tissues of liver cancer patients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 Aberrant DNA methylation is detected in pre- and postoperative blood samples and cancer and non-cancerous liver tissues.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with liver cancer undergoing liver resection
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku
TEL 03-5800-8844
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Ishizawa
Organization Graduate School of Medicine, University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
TEL
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Graduate School of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Cancer Institute Hospital of Japanese Foundation for Cancer Research
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
2008 Year 09 Month 10 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
Date of protocol fixation
2004 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2005 Year 05 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 08 Month 17 Day
Last modified on
2010 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001604

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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