UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001317 |
|---|---|
| Receipt number | 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 09:17:23 |
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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
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
tish-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001604
