UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027722 |
|---|---|
| Receipt number | R000031760 |
| Scientific Title | Genome and epigenome analysis of circulating free DNA and RNA-based liquid biopsy |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2021/06/14 17:50:15 |
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Basic information
Public title
Genome and epigenome analysis of circulating free DNA and RNA-based liquid biopsy
Acronym
Genome and epigenome analysis of circulating free DNA and RNA-based liquid biopsy
Scientific Title
Genome and epigenome analysis of circulating free DNA and RNA-based liquid biopsy
Scientific Title:Acronym
Genome and epigenome analysis of circulating free DNA and RNA-based liquid biopsy
Region
| Japan | North America | Europe |
Condition
Condition
Healthy adult astronauts
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Assessment of cellular response in human without invasive sampling combined with ultra-highthroughput sequencing technology should provide new insights on gene regulation in response to environmental stress. In this project, we intend to perform whole-genome profiling of blood-circulating cell-free DNA (cfDNA) and RNA (cRNA) to screen biomarkers for human stress response against space environment. The result will provide basis for non-invasive, quantitative and specific measurement of environmental stress in human. Such biomarkers are essential for monitoring human health during stay in space station and evaluation of countermeasures. This project also provides new insights, in non-biased, genome-wide scale, for understanding of biological responses against space radiation exposure and microgravity which induce symptoms related to aging.
Basic objectives2
Others
Basic objectives -Others
Measurememnt of cell-free DNA and RNA in plasma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After specimen collection and coding, plasma will be isolated from blood. DNA and RNA will be extracted from plasma which contains extra-cellular DNA and RNA circulating in blood stream. For pre-flight samples, additional DNA will be extracted from blood clot which remains in the sampling tube after removal of plasma. This genomic DNA will be used to read reference DNA sequence. By comparing DNA sequence obtained from in-flight plasma DNA sample with reference DNA, presence of DNA damage can be detected during the in-flight and post-flight time course samples.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Flight duration longer than 3 months
Key exclusion criteria
Avoid high-intensity exercise, muscle biopsy and sleep shift
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Muratani |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-7645
muratani@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Muratani |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-7645
Homepage URL
muratani@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
JAXA and public research funding
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Aerospace Exploration Agency (JAXA)
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
| 2017 | Year | 06 | Month | 12 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For time-course plasma samples,
- cfDNA amount (estimate copy number for multiple genomic location)
- damage or mutations in cfDNA
- cfDNA methylation status
- cRNA copy number
are estimated.
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031760
