UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034327 |
|---|---|
| Receipt number | R000039130 |
| Scientific Title | The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer |
| Date of disclosure of the study information | 2019/10/02 |
| Last modified on | 2018/09/29 18:34:05 |
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Basic information
Public title
The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer
Acronym
prostate biopsy with BjoJet system
Scientific Title
The evaluation of BjoJet system for accurate prostate biopsy for the patients with suspicious prostate cancer
Scientific Title:Acronym
prostate biopsy with BjoJet system
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether prostate biopsy can improve diagnosis rate and accurate prostate cancer localization diagnosis with the BioJet system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histopathological findings of biopsy tissue.
Analysis of difference between histopathological findings with image findings and specimens from total prostatectomy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Prostate biopsy with the BioJet system
one time
examination period is 30 minutes
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
Patients with high serum PSA (2.8 ng/ml or more, and 50 ng/ml or less).
Prostate cancer suspected patients with the mass in the prostate by rectal examination.
Patients with localized prostate cancer suspected by MRI.
Key exclusion criteria
Patients whose diagnosis of prostate cancer does not contribute to the patient's life prognosis.
Patients with serum PSA>50 ng/ml and suspected of progressive prostate cancer.
Patients with suspected progressive prostate cancer by rectal examination.
Patients with suspected progressive prostate cancer by MRI.
Patients with abnormal coagulation
Patients who are allergic to anesthetics and can not suffer from spinal subarachnoid anesthesia or sacral anesthesia.
Patients judged inappropriate in this study by the doctor.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayato Yamamoto |
Organization
Hirosaki University school of medicine and hospital
Division name
urology
Zip code
Address
5, Zaifu, Hirosaki, Aomori
TEL
0172395091
ha-yama@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayato Yamamoto |
Organization
Hirosaki University school of medicine and hospital
Division name
urology
Zip code
Address
5, Zaifu, Hirosaki, Aomori, Japan
TEL
0172395091
Homepage URL
ha-yama@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University school of medicine and hospital
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University school of medicine and hospital
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 10 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | 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
Management information
Registered date
| 2018 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039130
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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