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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010927
Receipt No. R000012786
Scientific Title Biomarker discovery and development of therapy for aortic aneurysm
Date of disclosure of the study information 2013/06/12
Last modified on 2013/06/11

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Basic information
Public title Biomarker discovery and development of therapy for aortic aneurysm
Acronym Biomarker discovery and development of therapy for aortic aneurysm
Scientific Title Biomarker discovery and development of therapy for aortic aneurysm
Scientific Title:Acronym Biomarker discovery and development of therapy for aortic aneurysm
Region
Japan

Condition
Condition Aortic aneurysm
Classification by specialty
Cardiology Vascular surgery Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim was to discover biomarkers to predict activity of aortic aneurysm and to develop pharmacological therapy for aortic aneurysm.
Basic objectives2 Others
Basic objectives -Others 1. Detection of biomarkers that correlate with activity and progression of aortic aneurysm.
2. Identification of proteins that contribute to progression of aortic aneurysm using organ culture of aortic tissues.
3. Development of drugs that inhibit the identified proteins.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Detection of biomarkers that correlate with activity and progression of aortic aneurysm.
2. Identification of proteins that contribute to progression of aortic aneurysm using organ culture of aortic tissues.
3. Development of drugs that inhibit the identified proteins.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Blood samples (5 ml per patient) are obtained from patients with aortic aneurysm. Aortic aneurysmal tissues are obtained at surgeres of blood vessel prosthesis implantation.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients over 20 years old.
Key exclusion criteria N/A
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Utako Yokoyama
Organization Yokohama City University Graduate School of Medicine
Division name Cardiovascular Research Insutitute
Zip code
Address 3-9 Fukuura Kanazawaku, Yokohama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama City University Graduate School of Medicine
Division name Cardiovascular Research Institute
Zip code
Address 3-9 Fukuura Kanazawaku, Yokohama, Japan
TEL
Homepage URL
Email

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research on Innovative Areas
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 12 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 11 Day
Last modified on
2013 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012786

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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