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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018332
Receipt No. R000021218
Scientific Title Assessment of ensuring radiation safety competence for release criteria following 125I prostate brachytherapy
Date of disclosure of the study information 2015/07/16
Last modified on 2015/07/16

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Basic information
Public title Assessment of ensuring radiation safety competence for release criteria following 125I prostate brachytherapy
Acronym Assessment of ensuring radiation safety competence for release criteria following 125I prostate brachytherapy
Scientific Title Assessment of ensuring radiation safety competence for release criteria following 125I prostate brachytherapy
Scientific Title:Acronym Assessment of ensuring radiation safety competence for release criteria following 125I prostate brachytherapy
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To use direct radiation exposure measurements to determine the degree and variability of expected life time exposure to the patient's family members with the aim of evaluating release criteria for patients after 125I prostate brachytherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Estimate lifetime exposure that patient's family members receive after the 125I prostate brachytherapy
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
35 years-old <=
Age-upper limit
100 years-old >
Gender Male
Key inclusion criteria Written informed consent must be obtained from patients and their family members
Key exclusion criteria 1) Patients less than 5 years life expectancy
2) Patients with distant metastases
3) Patients with metal allergy
4) Patients whom radiation therapy is contraindicated
5) Patients with bleeding
6) Patients with ascites, pleural effusion
7) Patients suspected with skin, pleura, peritoneum infection
8) Patients suspected with abscess, vascular disease
9) Patients who cannot be ensured a safe puncture route
10) Patients who cannot be transfused
11) Patients whom target site is confusing
12) Patients who are judged inappropriate for the clinical trial by doctors
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsunori Yorozu
Organization National Hospital Organization, Tokyo Medical Center
Division name Radiation Oncology
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo, 152-8902
TEL 03-3411-0111
Email ayorozu@ntmc.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsunori Yorozu
Organization National Hospital Organization, Tokyo Medical Center
Division name Radiation Oncology
Zip code
Address 2-5-1, Higashigaoka, Meguro-ku, Tokyo, 152-8902
TEL 03-3411-0111
Homepage URL
Email ayorozu@ntmc.hosp.go.jp

Sponsor
Institute National Hospital Organization, Tokyo Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 独立行政法人国立病院機構東京医療センター

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 16 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Presentation at the JGB-JASTRO's 17th Annual Meeting (Japanese Group of Brachytherapy/Japanese Society for Radiation Oncology) and World Congress on Medical Physics and Biomedical Engineering 2015
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 Completed
Date of protocol fixation
2013 Year 09 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study
Direct measurements is performed to patient's family members after 125I prostate brachytherapy

Management information
Registered date
2015 Year 07 Month 16 Day
Last modified on
2015 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021218

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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