UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055699 |
|---|---|
| Receipt number | R000063641 |
| Scientific Title | Development of a cooperative analysis system for biodosimetry using human peripheral blood among the Advanced Radiation Emergency Medical Support Centers |
| Date of disclosure of the study information | 2024/10/03 |
| Last modified on | 2024/10/03 10:14:45 |
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Basic information
Public title
Development of a cooperative analysis system for biodosimetry using human peripheral blood among the Advanced Radiation Emergency Medical Support Centers
Acronym
Development of a cooperative analysis system for biodosimetry among the Advanced Radiation Emergency Medical Support Centers
Scientific Title
Development of a cooperative analysis system for biodosimetry using human peripheral blood among the Advanced Radiation Emergency Medical Support Centers
Scientific Title:Acronym
Development of a cooperative analysis system for biodosimetry among the Advanced Radiation Emergency Medical Support Centers
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to establish a system for coordinated implementation of biodosimetry among Advanced Radiation Medical Support Centers, human peripheral blood, slide preparations and microscopic images of human peripheral blood mononuclear cells for chromosome aberration analysis will be transferred, and the procedures for transportation and analysis will be standardized so that appropriate biodosimetry can be performed in each case.
Basic objectives2
Others
Basic objectives -Others
(1) Standardization of blood sample transport procedures
(2) Standardization of dose estimation by sharing chromosome preparations
(3) Standardization of dose estimation by sharing microscopic images
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of blood coagulation and decreased proliferative activity, and estimated dose from chromosome aberration frequency.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults who are able to consent to participate in this study and who can read and understand the informed consent document.
Key exclusion criteria
Not applicable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kurihara |
Organization
National Institutes for Quantum Science and Technology
Division name
Department of Radiation Measurement and Dose Assessment, Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-4681
kurihara.osamu@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, Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-4734
Homepage URL
chromosome@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Nuclear Regulation Authority
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Hirosaki University, Fukushima Medical University, University of Fukui, Hiroshima University, Nagasaki University
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 03 | 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
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Standardization of blood sample transport procedures: Blood samples will be collected from research subjects at each research institute. Blood samples will be exchanged between institutes. The blood sample will be measured for coagulation and decreased proliferative activity.
(2) Standardization of dose estimation by sharing chromosome preparations: Peripheral blood samples collected in (1) are fractionated, or peripheral blood received from other institutions is irradiated with ionizing radiation to prepare chromosome preparations. Chromosomal preparations are transferred between laboratories. Microscopic images of the preparations are taken. The microscopic images are analyzed and dose estimation is performed.
(3) Standardization of dose estimation by sharing microscopic images: Microscopic images are taken of some of the chromosome preparations made in (2). The microscopic images are transferred between laboratories. The microscopic images are analyzed and dose estimation is performed.
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063641
