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

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 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

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

Value
https://center6.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