UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022635 |
|---|---|
| Receipt number | R000026095 |
| Scientific Title | Comparison of iron-containing marker and non-iron-containing marker for prostate radiotherapy |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2018/04/24 11:10:01 |
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Basic information
Public title
Comparison of iron-containing marker and non-iron-containing marker for prostate radiotherapy
Acronym
Comparison of two markers
Scientific Title
Comparison of iron-containing marker and non-iron-containing marker for prostate radiotherapy
Scientific Title:Acronym
Comparison of two markers
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare iron-containing marker with non-iron-containing marker for radiotherapy of prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the images MRI sequences by two observers using scoring.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
Performance status is 0 or 2
Key exclusion criteria
the patient with hematologic desease
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
Department of Radiation Oncology
Zip code
Address
Kashima-cho Gifu Gifu Japan
TEL
+81582511101
c.bluered@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Tanaka |
Organization
Gifu Municipal Hospital
Division name
Department of Radiation Oncology
Zip code
Address
7-1 kashima-cho Gifu Japan
TEL
+81582511101
Homepage URL
c.bluered@gmail.com
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
self
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
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
| 2016 | Year | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate efficacy and safety.
Management information
Registered date
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026095
