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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000418
Receipt No. R000000510
Scientific Title Unruptured Cerebral Aneurysm Study in Japan
Date of disclosure of the study information 2006/05/17
Last modified on 2012/11/12

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Basic information
Public title Unruptured Cerebral Aneurysm Study in Japan
Acronym UCAS Japan
Scientific Title Unruptured Cerebral Aneurysm Study in Japan
Scientific Title:Acronym UCAS Japan
Region
Japan

Condition
Condition Unruptured intracranial aneurysms
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clarify natural course of unruptured intracranial aneurysms and to prove that the annual rupture rate of unruptured intracranial aneurysms is more than 0.5%.
Basic objectives2 Others
Basic objectives -Others Clarify management risks of unruptured intracranial aneurysms
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Rupture rate of unruptured intracranial aneurysms during the initial 3 years after the confirmation of the aneurysms
Key secondary outcomes Management risks of the unruputred intracranial aneurysms

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 equal or more than 3mm in size
Key exclusion criteria No informed consent
Target sample size 8000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Kirino
Organization Department of Neurosurgery, Faculty of Medicine, University of Tokyo
Administrative office for UCAS Japan
Division name Neurosurgery
Zip code
Address 7-3-1, Hongo, BUnkyo-ku, Tokyo, japan
TEL 03-5800-8853
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akio Morita
Organization Faculty of medicine, University of Tokyo
Division name Neurosurgery
Zip code
Address 7-3-1Hongo, Bunkyo-ku TOkyo, Japan
TEL 03-5800-8853
Homepage URL http://ucas-j.umin.ac.jp/home.htm
Email ucasj-head@umin.ac.jp

Sponsor
Institute Society of Japan Neurosurgical Society
Institute
Department

Funding Source
Organization Minstry of Health, Welfare and Labor in Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Japan Neuorological Foundation

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

Other administrative information
Date of disclosure of the study information
2006 Year 05 Month 17 Day

Related information
URL releasing protocol http://ucas-j.umin.ac.jp/home.htm
Publication of results Published

Result
URL related to results and publications http://www.nejm.org/doi/full/10.1056/NEJMoa1113260
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 Completed
Date of protocol fixation
2000 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2001 Year 01 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 01 Month 01 Day
Date trial data considered complete
2011 Year 02 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information Patients with newly detected unruptured intracranial aneurysms during Januray 2001 till Aprial 2004 were registered. Either simply observed or treated patients were involved. Management strategy was determined by the patient's choice. Periodic follow-up at 3, 12 and 36months after intital entry were recorded. LAst patient follow-up should finish in April 2007.

Management information
Registered date
2006 Year 05 Month 12 Day
Last modified on
2012 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000510

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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