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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006906
Receipt No. R000008163
Scientific Title To evaluate intra-fractional prostate motion
Date of disclosure of the study information 2012/01/01
Last modified on 2016/12/22

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Basic information
Public title To evaluate intra-fractional prostate motion
Acronym To evaluate intra-fractional prostate motion
Scientific Title To evaluate intra-fractional prostate motion
Scientific Title:Acronym To evaluate intra-fractional prostate motion
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate intra-fractional prostate motion
Basic objectives2 Others
Basic objectives -Others observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intra-fractional prostate motion
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 Patients with the prostatatic calcification or a metal marker detect by IGRT system
2 PS = 0 or 1
Key exclusion criteria 1 Patients without the prostatatic calcification and a metal marker detect by IGRT system
2 Treatment posture cannot be held on a bed
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Department of Radiation Oncology and Image-applied Therapy
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL 075-751-3762
Homepage URL
Email mizo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University
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
Email

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 京都大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluate intra-fractional prostate motion by use of calcification or a metal marker within the prostate which can be detected by two orthogonal kv X rays

Management information
Registered date
2011 Year 12 Month 19 Day
Last modified on
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008163

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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