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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028276
Receipt No. 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 2017/07/18

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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
Middle name
Last name Keiichi Fukuda
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-3353-1211
Email kfukuda@a2.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Katsumata
Organization Keio University School of Medicine
Division name Department of Cardiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo
TEL 03-3353-1211
Homepage URL
Email goodcentury21@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 19 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2017 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.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


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