UMIN-CTR Clinical Trial

Basic information
Public title	Study of microRNA in blood and PBMCs collected from humans
Acronym	Study of microRNA in human blood samples
Scientific Title	Study of microRNA in blood and PBMCs collected from humans
Scientific Title:Acronym	Study of microRNA in human blood samples
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish a method of microRNA analysis of clinical samples for the aDB
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MicroRNA analysis methods are assessed for credibility and accuracy by measuring and comparing miRNA expression levels by methods such as microRNA chip, a next-generation sequencer and qPCR, and also by consulting the aDB study and other clinical studies. Nucleic acid is extracted from PBMCs and used for microRNA analysis.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adult weighing 50kg or more
Key exclusion criteria	Not obtained the consent
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken Ishii
Organization	National Institutes of Biomedical Innovation,Health and Nutrition
Division name	Laboratory of Adjuvant Innovation
Zip code
Address	7-6-8 Asagi Saito Ibaraki-City Osaka
TEL	072-641-8043
Email	kenishii@biken.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Ishii
Organization	National Institutes of Biomedical Innovation,Health and Nutrition
Division name	Laboratory of Adjuvant Innovation
Zip code
Address	7-6-8 Asagi Saito Ibaraki-City Osaka
TEL	072-641-8043
Homepage URL
Email	kenishii@biken.osaka-u.ac.jp

Sponsor
Institute	National Institutes of Biomedical Innovation,Health and Nutrition
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
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	2014 Year 01 Month 27 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	Completed
Date of protocol fixation	2013 Year 10 Month 16 Day
Date of IRB	2012 Year 09 Month 21 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Blood is collected at the maximum of 50 and 30 ml from men and women, respectively, at the interval of more than 2 weeks. The limit of blood collection is approximately 100 and 60 ml for men and women, respectively. Blood is processed by basic methods to prepare serum, plasma and PBMCs, and from those samples, nucleic acid containing microRNA is extracted by basic methods and analyzed by a microRNA chip or a next-generation sequencer.

Management information
Registered date	2014 Year 01 Month 27 Day
Last modified on	2019 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015124