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UMIN-CTR Clinical Trial |
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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 | 2020/11/24 |
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 |
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Condition | ||
Condition | Unruptured Intracranial Aneurysms | |
Classification by specialty |
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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 | |
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Eligibility | ||||
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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 |
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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 |
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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 | |
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 |
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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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 |
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Last modified on |
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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 |