UMIN-CTR Clinical Trial

Basic information
Public title	Influence of extraction and purification procedures on mRNA-based body fluid identification
Acronym	Influence of extraction procedures on mRNA-based body fluid identification
Scientific Title	Influence of extraction and purification procedures on mRNA-based body fluid identification
Scientific Title:Acronym	Influence of extraction procedures on mRNA-based body fluid identification
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The purpose of this study is to perform comparative analyses of the yield and quality of total RNA from various extraction anf purification procedures for mRNA-based identification of body fluid.
Basic objectives2	Others
Basic objectives -Others	Development of more effective mRNA-based identification method.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Estimation of size distribution of RNA and expression levels of target genes.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Normal adult.
Key exclusion criteria	The person who does not take medicine.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Sakurada
Organization	Tokyo Medical and Dental University
Division name	Department of Forensic Dentistry
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-55803-4387
Email	sakurada.fde@tmd.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Sakurada
Organization	Tokyo Medical and Dental University
Division name	Department of Forensic Dentistry
Zip code	113-8510
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-55803-4387
Homepage URL
Email	sakurada.fde@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Research Institute of Police Science, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel	0358034387
Email	sakurada.fde@tmd.ac.jp

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	2016 Year 08 Month 30 Day

Related information
URL releasing protocol	https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-26460895/
Publication of results	Published

Result
URL related to results and publications	https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-26460895/
Number of participants that the trial has enrolled	4
Results	RNA quality evaluation by RIN value showed that higher quality RNA was purified by the spin column method than by the magnetic bead method in blood, saliva and semen. On the other hand, since the magnetic bead method also extracts and purifies low-molecular-weight RNA, the real-time RT-PCR method had high sensitivity. When performing relative quantification by the dCt method, it was considered important to select an extraction/purification method and a control gene.
Results date posted	2022 Year 09 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Engaged in forensic examination.
Participant flow	Smoothly.
Adverse events	None
Outcome measures	Publication of papers, conference presentations.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 18 Day
Date of IRB	2014 Year 09 Month 11 Day
Anticipated trial start date	2014 Year 04 Month 18 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No problem.

Management information
Registered date	2016 Year 08 Month 30 Day
Last modified on	2022 Year 09 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027472