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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039430
Receipt No. 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 2020/08/11

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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
Email 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
Email kasuya.goro@qst.go.jp

Sponsor
Institute QST hospital
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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