UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029977 |
|---|---|
| Receipt number | 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 | 2019/11/20 09:46:17 |
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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 | Akio |
| Middle name | |
| Last name | Morita |
Organization
Nippon Medical School
Division name
Deparmtent of Neulogical Surgery
Zip code
1138603
Address
1-1-5, Sendagi, BUnkyo, Tokyo, Japan 1138603
TEL
03-3822-2131
amor-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Fumihiro |
| Middle name | |
| Last name | Matano |
Organization
Nippon Medical School
Division name
Department of Neurological Surgery
Zip code
1138603
Address
1-1-5 Sednagi, Bunkyo-ku, Tokyo, Japan 1138603
TEL
03-3822-2131
Homepage URL
mucep-office@umin.ac.jp
Sponsor or person
Institute
Department of Neurological Surgery, Nippon Medical School
Institute
Department
Personal name
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
Nippon Medical School Hospital
Address
1-1-5 Sendagi, Bunkyoku, Tokyo
Tel
03-3822-2131
nms_fuzokurinri@nms.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
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
| 2017 | Year | 07 | Month | 31 | Day |
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
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034240
| Research Plan | |
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| 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 |
