UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041815 |
|---|---|
| Receipt number | R000047739 |
| Scientific Title | Assessment of DNA methylation on MGMT gene in patients with glioma (a prospective study) |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2023/03/20 09:48:48 |
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Basic information
Public title
Assessment of DNA methylation on MGMT gene in patients with glioma (prospective study)
Acronym
DNA methylation on MGMT gene in glioma
Scientific Title
Assessment of DNA methylation on MGMT gene in patients with glioma (a prospective study)
Scientific Title:Acronym
DNA methylation on MGMT gene in glioma
Region
| Japan |
Condition
Condition
Glioma
Classification by specialty
| Neurosurgery | Adult | Child |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify whether results of MGMT methylation on MGMT gene from PCR test in our institute can predict therapeutic response of anti-cancer agents in patients with glioma
Basic objectives2
Others
Basic objectives -Others
Assessment of accuracy in results from PCR test in our Institute
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between MGMT methylation and overall survival period
Key secondary outcomes
Relationship between MGMT methylation and progression-free survival period
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo surgical tumor removal as well as will receive chemotherapy for glioma
Key exclusion criteria
Patients who have double cancers
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Beppu |
Organization
Iwate Medical University
Division name
Neurosurgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa, Iwate Prefecture
TEL
019-613-7111
tbeppu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Beppu |
Organization
Iwate Medical University
Division name
Neurosurgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba, Shiwa, Iwate Prefecture
TEL
019-613-7111
Homepage URL
tbeppu@iwate-med.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for JSPS KAKENHI from the Ministry of Education,Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Iwate Medical University
Address
1-1-1 Idaidori, Yahaba, Shiwa, Iwate Prefecture
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.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
岩手医科大学病院（岩手県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | 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
| 2020 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2000 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using tumor tissue obtained from surgical removal for patients with glioma, we will assess MGMT gene status is either methylation or unmethylation. After standard treatment, patients are assigned to 2 groups, methylated MGMT and unmethylated MGMT. We will compare therapeutic response, progression-free survival time, and overall survival time between 2 groups.
Management information
Registered date
| 2020 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
