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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000420
Receipt No. R000000511
Scientific Title Prospective Quality of Life Assessment of Unruptured Cerebral Aneurysms
Date of disclosure of the study information 2006/05/20
Last modified on 2020/05/18

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Basic information
Public title Prospective Quality of Life Assessment of Unruptured Cerebral Aneurysms
Acronym UCAS II
Scientific Title Prospective Quality of Life Assessment of Unruptured Cerebral Aneurysms
Scientific Title:Acronym UCAS II
Region
Japan

Condition
Condition Unruptured Intracranial Aneurysms
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 assess quality of life in patients with unruputured instracranial aneurysms
Basic objectives2 Others
Basic objectives -Others Clarify long term outcome of patients with unruptured intracranial aneurysms
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Quality of life of patients with unruptured intracranial aneurysms using SF-8, EQ5D and SF-36 mental score. Date will be obtained at the day of identification, 3months, and 12 months as well as post-treatment if any treatment are performed.
Key secondary outcomes Long term outcome of the patients with unruptured intracranial aneurysms including Mdified Rankin scale, QOL, rupture or other evets during the 1st year through the 6th year.

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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Aneurysm more than 3mm in size
Key exclusion criteria Initial Rankin scale more than 2
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Morita
Organization Nippon Medical School
Division name Department of Neurological Surgery
Zip code 113-8603
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email amor-tky@umin.ac.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Morita
Organization NIppon Medical School
Division name Neurosurgery, Administrative office for UCAS II
Zip code 113-8603
Address 1-1-5 Sednagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL 03-3822-2131
Homepage URL https://center.umin.ac.jp/islet/ucas2/
Email ucas2-head@umin.ac.jp

Sponsor
Institute U-CARE group: Unruptured Cerebral Aneurysm study for better Risk communication and Evidence-based decision making granted by Minstry of Health, Welfare and Labor
Institute
Department

Funding Source
Organization Minstry of Health, Welfare, and Labor
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 Univeristy of Tokyo
Address 7-3-1 Hongo Bunkyo-ku
Tel 03-3815-5411
Email akirasan-tky@umin.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
2006 Year 05 Month 20 Day

Related information
URL releasing protocol https://center.umin.ac.jp/islet/ucas2/
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 No longer recruiting
Date of protocol fixation
2005 Year 10 Month 20 Day
Date of IRB
2006 Year 01 Month 01 Day
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2014 Year 02 Month 01 Day

Other
Other related information Patients with newly diagnosed unruptured intracranial aneurysm during Jan. 2006 till Dec. 2006 are/ will be reggistered. Periodic follow-up at 3, 12 months and at the 6th year will be followed. Pateint's status, QOL, MMSE and 3D imaing will be acquired and analysed.

Management information
Registered date
2006 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000511

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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