UMIN-CTR Clinical Trial

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
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Interventions/Control_2
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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
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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
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Results Delayed
Results Delay Reason
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031760