UMIN-CTR Clinical Trial

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
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	2019 Year 11 Month 24 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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