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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003196
Receipt No. R000003871
Scientific Title Genetic analysis of prognosis-related factors in gliomas: methylation of MGMT, LOH of 1p/19q, and mutation of IDH1/2.
Date of disclosure of the study information 2010/02/22
Last modified on 2010/02/16

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Basic information
Public title Genetic analysis of prognosis-related factors in gliomas: methylation of MGMT, LOH of 1p/19q, and mutation of IDH1/2.
Acronym Genetic analysis of prognostic factors in gliomas.
Scientific Title Genetic analysis of prognosis-related factors in gliomas: methylation of MGMT, LOH of 1p/19q, and mutation of IDH1/2.
Scientific Title:Acronym Genetic analysis of prognostic factors in gliomas.
Region
Japan

Condition
Condition Glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Through the genetic analysis of gliomas, to evaluate the relations of the response to therapy and the prognosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Progression free survival, Overall survival
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Take a blood sample to examine DNA in a patient's lymphocyte.
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 The patient who has undergone definite diagnosis.
Key exclusion criteria Who does not consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KANNO, Hiroshi
Organization Yokohama City University of Medicine
Division name Department of Neurosurgery
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name YAMADA, Sachiko
Organization Yokohama City University of Medicine
Division name Department of Neurosurgery
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama Kanagawa
TEL 045-787-2800
Homepage URL
Email syamada-ykh@umin.ac.jp

Sponsor
Institute Yokohama City University of Medicine
Institute
Department

Funding Source
Organization Public organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 22 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 Open public recruiting
Date of protocol fixation
2010 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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

Management information
Registered date
2010 Year 02 Month 16 Day
Last modified on
2010 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003871

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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