UMIN-CTR Clinical Trial

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