UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000418 |
|---|---|
| Receipt number | 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 09:15:47 |
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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
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
ucasj-head@umin.ac.jp
Sponsor or person
Institute
Society of Japan Neurosurgical Society
Institute
Department
Personal name
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
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
Value
https://center6.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 |
