UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028276 |
|---|---|
| Receipt number | R000032370 |
| Scientific Title | Establishment of a System for Precision Medicine of Cardiovascular Diseases |
| Date of disclosure of the study information | 2017/07/19 |
| Last modified on | 2023/01/22 14:58:02 |
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Basic information
Public title
Establishment of a System for Precision Medicine of Cardiovascular Diseases
Acronym
Precision Medicine of Cardiovascular Diseases
Scientific Title
Establishment of a System for Precision Medicine of Cardiovascular Diseases
Scientific Title:Acronym
Precision Medicine of Cardiovascular Diseases
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to establish a system to elucidate the disease pathogenesis by understanding the relations among genetic information of the patients, transcriptome profiling, and epigenetic information of diseased tissues.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to establish a system to elucidate the disease pathogenesis by understanding the relations among genetic information of the patients, transcriptome profiling, and epigenetic information of diseased tissues.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Variants
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with heart, vessel, or connective tissue disease
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
0333531211
goodcentury21@keio.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Katsumata |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
0333531211
Homepage URL
goodcentury21@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi Shinjuku-ku
Tel
0333531211
goodcentury21@keio.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
| 2017 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032370
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
20
Results
No genomic and transcriptomic alterations characteristic of the common phenotype were observed.
Results date posted
| 2023 | Year | 01 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
atients with cardiovascular disease
Participant flow
Patients with cardiovascular disease were informed of the study and their written informed consent was obtained.
Adverse events
none
Outcome measures
Exome analysis, transcriptome analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 11 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 11 | Day |
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 09 | Month | 29 | Day |
Other
Other related information
The relationship between those analyses and individual patient's phenotypes
Management information
Registered date
| 2017 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032370
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
