UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003196 |
|---|---|
| Receipt number | 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 16:23:26 |
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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
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
syamada-ykh@umin.ac.jp
Sponsor or person
Institute
Yokohama City University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003871
