UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038023 |
|---|---|
| Receipt number | R000043342 |
| Scientific Title | Elucidation of factors involved in formation of intracranial giant cerebral aneurysm |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2019/09/17 13:40:47 |
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Basic information
Public title
Elucidation of factors involved in formation of intracranial giant cerebral aneurysm
Acronym
Elucidation of factors involved in formation of intracranial giant cerebral aneurysm
Scientific Title
Elucidation of factors involved in formation of intracranial giant cerebral aneurysm
Scientific Title:Acronym
Elucidation of factors involved in formation of intracranial giant cerebral aneurysm
Region
| Japan |
Condition
Condition
cerebral aneurysm
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Elucidation of factors involved in intracranial giant aneurysm formation
Basic objectives2
Others
Basic objectives -Others
Elucidation of factors involved in intracranial giant aneurysm formation
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proteomics, hormones, and genetic analysis of blood from patients with intracranial aneurysms
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with intracranial aneurysms in brain imaging and undergoing endovascular treatment
Key exclusion criteria
Patients who did not wish to participate in the study.
Patients who did not wish to undergo genetic testing.
Other patients who are judged to be ineligible by the research doctor.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Izumi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
4668550
Address
65 Tsurumai-cho Showa-ku Nagoya, Aichi
TEL
+81-52-744-2353
my-yuzu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Izumi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
4668550
Address
65 Tsurumai-cho Showa-ku Nagoya, Aichi
TEL
+81-52-744-2353
Homepage URL
my-yuzu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho Showa-ku Nagoya, Aichi
Tel
+81-52-741-2111
ethics@med.nagoya-u.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
| 2019 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For patients who have been diagnosed with intracranial cerebral aneurysms, proteomics analysis from blood samples, analysis of pituitary / sex hormone concentrations and concentrations of their metabolites, genetic polymorphism, etc. Blood samples are collected from the endovascular treatment, and outpatients.
A questionnaire about lifestyle habits is given to, patients who have agreed to the study Collect information.
Management information
Registered date
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043342
