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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034968
Receipt No. R000039873
Scientific Title Effect of radiation according to therapeutic nuclear medicine on DNA
Date of disclosure of the study information 2018/11/22
Last modified on 2019/05/23

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

Condition
Condition Thyroid cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect and quantify the DNA damage according to therapeutic 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 bef
ore I-131 administration and three days after administration.
Key secondary outcomes correlation between DNA damage and blood sample data/history/therapeutic record/I-131 dose/emitted radiation dose from patient.

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 Patients who are administered I-131 for therapeutic purpose in isolation room.
Key exclusion criteria Patients who are pregnant or possibly pregnant.
Patients who are performing breast feeding to baby.
Target sample size 90

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 8258523
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 IRB of Nagasaki University Hospital
Address 1-7-1 Sakamoto, Nagasaki, Japan
Tel 095-819-7229
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 11 Month 22 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 11 Month 19 Day
Date of IRB
2018 Year 11 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 01 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 11 Month 21 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039873

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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