UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032905 |
|---|---|
| Receipt number | 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 09:57:26 |
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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
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
rwatcvm@tmd.ac.jp
Sponsor or person
Institute
Department of Human Genetics and Disease Diversity, Tokyo Medical and Dental University.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037509
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