UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041209 |
|---|---|
| Receipt number | R000047060 |
| Scientific Title | Retrospective study for brain tumor related epilepsy in metastatic brain tumor |
| Date of disclosure of the study information | 2020/07/26 |
| Last modified on | 2020/07/26 16:46:08 |
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Basic information
Public title
Retrospective study for brain tumor related epilepsy in metastatic brain tumor
Acronym
Brain tumor related epilepsy in metastatic brain tumor
Scientific Title
Retrospective study for brain tumor related epilepsy in metastatic brain tumor
Scientific Title:Acronym
BTRE-R
Region
| Japan |
Condition
Condition
Brain tumor related epilepsy in metastatic brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
All patients who had experience of brain tumor related epilepsy (BTRE) due to metastatic brain tumors are registered, and our project pick up risk factors of BTRE. Our final object is to make plan for the prospective clinical trial of prophylactic administration of ant-epileptic drugs(AED).
Basic objectives2
Others
Basic objectives -Others
Retrospective study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
initial epileptic attack
Key secondary outcomes
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
| 10 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
metastatic brain tumor patients due to systematic cancer
Key exclusion criteria
CSF dissemination without cerebral parenchymal metastasis
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
asanoken@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Asano |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
036-8562
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
TEL
0172-39-5115
Homepage URL
asanoken@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Hirosaki University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Committee of Medical Ethics of Hirosaki University Graduate School of Medicine,Hirosaki,Japan
Address
Zaifu-Cho 5, Hirosaki-Shi, Aomori Prefecture, 036-8562, Japan
Tel
0172-33-5111
jm5194@hirosaki-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 26 | 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
606
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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047060
