UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000420 |
|---|---|
| Receipt number | 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 | 2021/05/26 10:27:38 |
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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
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/
ucas2-head@umin.ac.jp
Sponsor or person
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
Personal name
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
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
1050
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Statistical analysis not finished
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
| 2022 | 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
| 2021 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.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 |
