UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025095 |
|---|---|
| Receipt number | R000028856 |
| Scientific Title | Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2017/04/22 14:33:41 |
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Basic information
Public title
Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Acronym
Evaluation of urine volume and prostate position
Scientific Title
Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer
Scientific Title:Acronym
Evaluation of urine volume and prostate position
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of intravesical urine volume on prostate position during radiotherapy for prostate cancer.
Basic objectives2
Others
Basic objectives -Others
Internal organ motion
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between urine volume and positional changes of prostate during radiotherapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patient with prostate cancer who was received proton beam therapy at Hokkaido University Hospital from 1 April 2016 until 31 August 2016.
Those who refuse to participate in this research.
Key exclusion criteria
1. Patients who refused urine volume measurement by ultrasonic diagnostic equipment.
2. Patients who could not be performed prostate location verification using real-time tumor tracking system.
3. Other patients whose research managers judged inappropriate as research subjects.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Shirato |
Organization
Hokkaido university graduate school of medicine
Division name
Department of Radiation medicine
Zip code
Address
Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
shirato@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Nishioka |
Organization
Hokkaido university graduate school of medicine
Division name
Department of Radiation oncology
Zip code
Address
Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5977
Homepage URL
k.nishioka@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observation study using existing clinical information acquired from April 1st to August 31st 2016, and the results are currently being analyzed.
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2017 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028856
