UMIN-CTR Clinical Trial

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
Email	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
Email	asanoken@hirosaki-u.ac.jp

Sponsor
Institute	Department of Neurosurgery, Hirosaki University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047060