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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029977
Receipt No. R000034240
Scientific Title Prospective risk analysis of Management on Unruptured Cerebral Aneurysms in the Elderlies Japan (MUCE-P)
Date of disclosure of the study information 2017/11/15
Last modified on 2017/11/15

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Basic information
Public title Prospective risk analysis of Management on Unruptured Cerebral Aneurysms in the Elderlies Japan (MUCE-P)
Acronym MUCE-P
Scientific Title Prospective risk analysis of Management on Unruptured Cerebral Aneurysms in the Elderlies Japan (MUCE-P)
Scientific Title:Acronym MUCE-P
Region
Japan

Condition
Condition Unruptured cerebral aneurysms in elderlies ( age>60) considered for treatment
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identify risk factors related with the outcome of management of unruptured cerebral aneurysms in elderly patients
Basic objectives2 Others
Basic objectives -Others Influence of frail index on the clinical outcome
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Morbidity and mortality after treatment (1month and 1 year)
modified Rankin scale (1month and 1 year),
MMSE (1month and 1 year)
Key secondary outcomes Other complications such as chronic subdural hematomas
Image changes

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
60 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients >=60 years old with unruptured cerebral aneurysm being planned for treatment
Consent to join the sutudy
Key exclusion criteria age <60
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Morita
Organization Nippon Medical School
Division name Deparmtent of Neulogical Surgery
Zip code
Address 1-1-5, Sendagi, BUnkyo, Tokyo, Japan 1138603
TEL 03-3822-2131
Email amor-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Matano
Organization Nippon Medical School
Division name Department of Neurological Surgery
Zip code
Address 1-1-5 Sednagi, Bunkyo-ku, Tokyo, Japan 1138603
TEL 03-3822-2131
Homepage URL
Email mucep-office@umin.ac.jp

Sponsor
Institute Department of Neurological Surgery, Nippon Medical School
Institute
Department

Funding Source
Organization Nippon Medical School
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
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 日本医科大学付属病院
日本医科大学 千葉北総病院
日本医科大学 武蔵小杉病院
日本医科大学 多摩永山病院
博慈会記念病院
亀田総合病院
札幌禎心会病院
中村記念病院
旭川赤十字病院
函館脳神経外科病院
弘前大学脳神経外科
秋田脳研究所付属病院
熊本済生会病院
杏林大学医学部付属病院
東京警察病院
昭和大学医学部付属病院
広島大学医学部付属病院
防衛医科大学 
岩手医科大学
岡山大学
川崎医科大学
東京医科大学

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 15 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 06 Month 30 Day
Date trial data considered complete
2021 Year 09 Month 30 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information Recrouting

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034240

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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