UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048513 |
|---|---|
| Receipt number | R000055220 |
| Scientific Title | Development and research of biodosimetry method by genome analysis using human peripheral blood. |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/08/15 17:42:51 |
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Basic information
Public title
Development and research of biodosimetry method by genome analysis using human peripheral blood.
Acronym
Development and research of biodosimetry method by genome analysis.
Scientific Title
Development and research of biodosimetry method by genome analysis using human peripheral blood.
Scientific Title:Acronym
Development and research of biodosimetry method by genome analysis.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop a dose estimation method using the mutations of genomic DNA in cells of peripheral blood as an index after irradiation of ionizing radiation.
Basic objectives2
Others
Basic objectives -Others
(i) Development of a method for detecting mutations in genomic DNA.
We will develop a method for detecting mutations in genomic DNA using the sequence data of unirradiated samples and the reference sequence of the human genome.
(ii) Development of dose-effect curve formula based on DNA sequence mutation.
Using the method developed in (i), we analyze the relationship between the type and frequency of mutations and the irradiation dose, and create a dose-effect curve formula.
(iii) Examination of developed dose-effect curve formula.
In order to examine the effectiveness of the dose-effect curve formula developed in (ii), the irradiation dose is estimated for peripheral blood mononuclear cells irradiated with a constant dose of ionizing radiation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Types and frequencies of mutations in the nucleotide sequence of genomic DNA in cells 2 hours or later after irradiation of ionizing radiation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A healthy person capable of giving consent for participation in this study and who can read and understand the consent document.
Key exclusion criteria
Persons who have been or may be found to have coerced a socially vulnerable person.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Ishii |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-6294
ishii.kotaro@qst.go.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Ishii |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-6294
Homepage URL
ishii.kotaro@qst.go.jp
Sponsor or person
Institute
Department of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences, National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Department of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences, National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
043-206-4709
helsinki@qst.go.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
国立研究開発法人量子科学技術研究開発機構（千葉県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(i) Development of methods for detecting mutations induced in genomic DNA.
We collect up to 20 mL of peripheral blood from participants. Genomic DNA of peripheral blood mononuclear cell is sequenced and the obtained sequence data are mapped to the human reference genome sequence.
(ii) Development of dose-effect curve formula based on mutation of DNA sequence.
We collect up to 20 mL of peripheral blood from participants. The peripheral blood is irradiated with ionizing radiation in the range of 0-30 Gy to imitate the exposure. Genome sequencing of peripheral blood mononuclear cells and mutation analysis are performed. A dose-effect curve formula based on the analysis results are created.
(iii) Examination of the developed dose estimation curve formula.
We collect up to 20 mL of peripheral blood from participants. The peripheral blood is irradiated with ionizing radiation in the range of 0-30 Gy to imitate the exposure. Genome sequencing of peripheral blood mononuclear cells and mutation analysis are performed. By using the dose-effect curve formula, dose estimations are performed.
Management information
Registered date
| 2022 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055220
