UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026709 |
|---|---|
| Receipt number | R000030662 |
| Scientific Title | Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2017/03/26 20:15:00 |
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Basic information
Public title
Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer
Acronym
Biojet system for the prostate biopsy
Scientific Title
Examination of the efficacy of the MRI-TRUS fusion biopsy (Biojet) system against prostate cancer
Scientific Title:Acronym
Biojet system for the prostate biopsy
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and efficiency of the Biojet system against the patients suspicious of prostate cancer with high PSA levels
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate of clinically significant 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
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male
Key inclusion criteria
1) PSA level (2.8-50ng/ml)
2) Suspicious of localized prostate cancer by digital rectal examination
3) Suspicious of localized prostate cancer by MRI
4) patients who was obtained informed consent
Key exclusion criteria
1) Suspicious of invasive prostate cancer by digital rectal examination
2) Suspicious of invasive prostate cancer by MRI
3) Patients with coagulation disorder
4) Patients who can not be performed TRUS because of anal stenosis
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
Address
1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL
052-853-8266
hamamo10@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuzo Hamamoto |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Nephro-urology
Zip code
Address
1 Kawasumi Muzuho-cho, Mizuho-Ku, Nagoya, Japan
TEL
052-853-8266
Homepage URL
hamamo10@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University 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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before the study
Management information
Registered date
| 2017 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030662
