UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010927 |
|---|---|
| Receipt number | 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 13:08:30 |
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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
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
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012786
