UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039430 |
|---|---|
| Receipt number | R000044952 |
| Scientific Title | DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2021/08/10 11:38:52 |
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Basic information
Public title
DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Acronym
DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Scientific Title
DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Scientific Title:Acronym
DVH analyses at urination between before and after by using 4DCT for the patients with prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the affection due to the difference of DVH between before and after urination for the patients with prostate cancer
Basic objectives2
Others
Basic objectives -Others
The change in the location of each organ
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The dose to bladder and rectum and planning target volume according to DVH analyses
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
1)The patients who are treated with carbon-ion radiotherapy
2) Patients who hope to participate in this study
Key exclusion criteria
1) having abnormal by examination after concent
2) Patients who have difficulty performing CT imaging
3) Patient after femoral head replacement
4)Those who are judged by the doctor to be ineligible for the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
QST hospital
Division name
treatment section
Zip code
263-8555
Address
4-9-1 anagawa inage-ku chiba
TEL
04320633306
kasuya.goro@qst.go.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
QST hospital
Division name
treatment section
Zip code
263-8555
Address
4-9-1 anagawa inage-ku chiba
TEL
04320633306
Homepage URL
kasuya.goro@qst.go.jp
Sponsor or person
Institute
QST hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum and Radiological Science and Technology Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel
0 4 3 -2 0 6 -4 7 0 6
helsinki@qst.go.jp
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
QST病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 10 | 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
20
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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study to analyze and compare DVH by taking two treatment planning CTs during bladder collapse and one-hour urine collection
Management information
Registered date
| 2020 | Year | 02 | Month | 07 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044952
