UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000037509