UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026501 |
|---|---|
| Receipt number | R000030435 |
| Scientific Title | Comparison of position of the prostate using fiducial marker and prostate outline for Intensity Modulated Radiotherapy. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/12/08 11:19:55 |
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Basic information
Public title
Comparison of position of the prostate using fiducial marker and prostate outline for Intensity Modulated Radiotherapy.
Acronym
Comparing study of prostate position in IMRT setting.
Scientific Title
Comparison of position of the prostate using fiducial marker and prostate outline for Intensity Modulated Radiotherapy.
Scientific Title:Acronym
Comparing study of prostate position in IMRT setting.
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the position of the prostate between guided by fiducial marker and outline of the prostate in radiotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of the three direction of the prostate using fiducial marker and prostate outline using CT image.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Localized prostate cancer
Key exclusion criteria
Patient with no agreement on this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Yama |
Organization
Gifu Municipal Hospital
Division name
Division of Radiation Service
Zip code
50085113
Address
7-1 Kashima-cho Gifu
TEL
058-251-1101
kuwatoro_eiichi@msn.com
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Yama |
Organization
Gifu Municipal Hospital
Division name
Division of Radiation Service
Zip code
5008513
Address
7-1 Kashima-cho Gifu
TEL
81-58-251-1101
Homepage URL
kuwatoro_eiichi@msn.com
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
GMH
Address
Kashima-cho 7-1
Tel
0582511101
c.bluered@gmail.com
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
| 2017 | Year | 04 | Month | 01 | 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
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of CT images for daily clinical.
Management information
Registered date
| 2017 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030435
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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