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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019402
Receipt No. R000022253
Scientific Title Comparison of the MRI sequence using different size of fidicual gold marker for intensity modulated radiotherapy for prostate cancer
Date of disclosure of the study information 2015/10/19
Last modified on 2018/04/24

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Basic information
Public title Comparison of the MRI sequence using different size of fidicual gold marker for intensity modulated radiotherapy for prostate cancer
Acronym Comparison of MRI sequence for prostate size and fidicual marker
Scientific Title Comparison of the MRI sequence using different size of fidicual gold marker for intensity modulated radiotherapy for prostate cancer
Scientific Title:Acronym Comparison of MRI sequence for prostate size and fidicual marker
Region
Japan

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

Objectives
Narrative objectives1 To find an ideal Magnetic resonance imaging for detectiong the gold fidicual marker and outline of the prostate.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes To find the ideal Magnetic resonance sequence for localized prostate cancer.
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male
Key inclusion criteria The patient gave their written informed consent
Key exclusion criteria Patient who reject our study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Tanaka
Organization Gifu Municipal Hospital
Division name Radiation Oncology
Zip code
Address 7-1 Kashima-cho Gifu
TEL 81-58-251-1101
Email osa0508@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Tanaka
Organization Gifu Municipal Hospital
Division name Radiation Oncology
Zip code
Address 7-1 Kashima-cho Gifu
TEL 81-58-251-1101
Homepage URL
Email osa0508@yahoo.co.jp

Sponsor
Institute Gifu Municipal Hospital
Institute
Department

Funding Source
Organization Gifu Municipal Hospital
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 岐阜市民病院

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study.
The patients are treated in our hospital.
Observing time is between 2015 October to 2016 March.The patients give their written informed consent.

Management information
Registered date
2015 Year 10 Month 19 Day
Last modified on
2018 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022253

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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