UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018332 |
|---|---|
| Receipt number | 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 14:13:15 |
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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
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
ayorozu@ntmc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Tokyo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021218
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
