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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027722
Receipt No. 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 2017/06/14

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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
Email 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
Email muratani@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 14 Day
Last follow-up date
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
2017 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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