UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023844 |
|---|---|
| Receipt number | R000027472 |
| Scientific Title | Influence of extraction and purification procedures on mRNA-based body fluid identification |
| Date of disclosure of the study information | 2016/08/30 |
| Last modified on | 2022/09/05 09:25:54 |
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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
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
sakurada.fde@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027472
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
