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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000025095 |
Receipt No. | R000028856 |
Official scientific title of the study | 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 |
Basic information | ||
Official scientific title of the study | Evaluation of intravesical urine volume and prostate position in radiotherapy of prostate cancer | |
Title of the study (Brief title) | Evaluation of urine volume and prostate position | |
Region |
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Condition | |||
Condition | Prostate cancer | ||
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 10 |
Research contact person | |
Name of lead principal investigator | Hiroki Shirato |
Organization | Hokkaido university graduate school of medicine |
Division name | Department of Radiation medicine |
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 | Kentaro Nishioka |
Organization | Hokkaido university graduate school of medicine |
Division name | Department of Radiation oncology |
Address | Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo, Hokkaido |
TEL | 011-706-5977 |
Homepage URL | |
k.nishioka@med.hokudai.ac.jp |
Sponsor | |
Institute | Hokkaido university |
Institute | |
Department |
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) |
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 |
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Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028856 |
Research Plan | ||
Registered date | Registrant | File name |
Research case data specifications | ||
Registered date | Registrant | File name |
Research case data | ||
Registered date | Registrant | File name |