UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041655 |
|---|---|
| Receipt number | R000047256 |
| Scientific Title | Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/12/20 15:54:38 |
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Basic information
Public title
Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Acronym
Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Scientific Title
Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Scientific Title:Acronym
Evaluation of the affect in the detection of significant prostate cancer by the characteristics of the biopsy needle
Region
| Japan |
Condition
Condition
Suspected prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability in the detection of prostate cancer in 3 types of the needle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sample quality of the prostate biopsy cores, Relationship between MRI finding and pathological findings of the prostate biopsy
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
| Not applicable |
Gender
Male
Key inclusion criteria
1.Prostate cancer suspected person who are able to be receive MRI-TRUS fusion image-guided biopsy.
2.Prostate cancer suspected person with PI-RADS 4,5lesions identified on MRI.
3.Prstate cancer suspected person who agree with informed consent.
Key exclusion criteria
1.Prstate cancer suspected person who disagree with informed consent.
2.Person who are regarded as inappropriate for the study by the researcher.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Sunao |
| Middle name | |
| Last name | Shoji |
Organization
Tokai University
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
sunashoj@mail.goo.ne.jp
Public contact
Name of contact person
| 1st name | Mayura |
| Middle name | |
| Last name | Nakano |
Organization
Tokai University
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya,Isehara,Kanagawa
TEL
0463-93-1121
Homepage URL
mayura1212@gmail.com
Sponsor or person
Institute
Tokai University
School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai 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
Institutional Review Board for Clinical Research,Tokai University
Address
143 Shimokasuya,Isehara,Kanagawa
Tel
0463931121
tokai-rinsho@ml.tokai-u.jp
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
| 2020 | Year | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047256
