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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032905
Receipt No. R000037509
Scientific Title Exploration of biomarkers for cardiac sarcoidosis.
Date of disclosure of the study information 2018/06/07
Last modified on 2019/12/09

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Basic information
Public title Exploration of biomarkers for cardiac sarcoidosis.
Acronym Exploration of biomarkers for cardiac sarcoidosis.
Scientific Title Exploration of biomarkers for cardiac sarcoidosis.
Scientific Title:Acronym Exploration of biomarkers for cardiac sarcoidosis.
Region
Japan

Condition
Condition cardiac sarcoidosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study aims to detect specific microRNAs and mutation in the patients. Samples from patients are not collected because we use existing samples (serum, consent acquired) stored at the bioresource center, Tokyo Medical and Dental University. Only serum samples from healthy volunteers as controls are collected.
Basic objectives2 Others
Basic objectives -Others Expression analysis of transcript and detection of mutation.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We extract RNA and DNA from serum or circulating exosome, examine microRNA expression and mutation.
Key secondary outcomes Measurement of exosome concentration in the circulating blood.

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
Maneuver
Interventions/Control_1 Blood sampling (about 7 ml) is done one time from staffs of Tokyo Medical and Dental University. Separate serum after collection.
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 Staffs of Tokyo Medical and Dental University.
We do not exclude by gender and age.
Key exclusion criteria none.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Maejima
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5231
Email ymaeji.cvm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Watanabe
Organization Tokyo Medical and Dental University
Division name Department of Human Genetics and Disease Diversity
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4662
Homepage URL
Email rwatcvm@tmd.ac.jp

Sponsor
Institute Department of Human Genetics and Disease Diversity, Tokyo Medical and Dental University.
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology Japan.
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
2018 Year 06 Month 07 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
2017 Year 03 Month 02 Day
Date of IRB
2017 Year 03 Month 02 Day
Anticipated trial start date
2017 Year 06 Month 06 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2019 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037509

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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