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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038023
Receipt No. 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

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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
Email 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
Email my-yuzu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043342

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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