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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034573
Receipt No. R000039413
Scientific Title Effect of radiation according to diagnostic nuclear medicine on DNA
Date of disclosure of the study information 2018/10/19
Last modified on 2019/04/20

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Basic information
Public title Effect of radiation according to diagnostic nuclear medicine on DNA
Acronym Effect of diagnostic nuclear medicine on DNA
Scientific Title Effect of radiation according to diagnostic nuclear medicine on DNA
Scientific Title:Acronym Effect of diagnostic nuclear medicine on DNA
Region
Japan

Condition
Condition All the diseases which FDG PET imaging are approved.
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect and quantify the DNA damage according to diagnostic nuclear medicine procedures with gamma-H2AX and chromosomal analysis using FISH method. Equality of detection power of DNA damage using gamma-H2AX measuring and chromosomal analysis is also assessed.
Basic objectives2 Others
Basic objectives -Others Radiation effect
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of DNA damage between before FDG injection, before FDG PET image aquisition and after aquisition.
Key secondary outcomes correlation between DNA damage and blood sample data/history/FDG dose/FDG PET acquisition parameters.

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 Who are perfomed FDG PET/CT due to the diseases which are approved for FDG PET imagings.
Key exclusion criteria Patients with histroy of FDG PET examination with in one year.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Kudo
Organization Nagasaki University
Division name Department of Radioisotope Medicine, Atomic Bomb Disease Institute
Zip code 8528523
Address 12-4 Sakamoto-1-chome, Nagasaki, Nagasaki
TEL 095-819-7101
Email tkudo123@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name TAKASHI
Middle name
Last name KUDO
Organization Nagasaki University
Division name Department of Radioisotope Medicine, Atomic Bomb Disease Institute
Zip code 8528523
Address 12-4 Sakamoto-1-chome, Nagasaki, Nagasaki
TEL 095-819-7101
Homepage URL
Email tkudo123@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Hospital
Address 7-1 Sakamoto-1chome, Nagasaki
Tel 095-819-7200
Email gaibushikin@ml.nagasaki-u.ac.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
2018 Year 10 Month 19 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
2018 Year 10 Month 15 Day
Date of IRB
2018 Year 09 Month 23 Day
Anticipated trial start date
2018 Year 10 Month 22 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will acquire DNA damage measurement. Data are not yet achieved.

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039413

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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