UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042475 |
|---|---|
| Receipt number | R000048023 |
| Scientific Title | Evaluation of the new prostate biopsy strategy for the detection of the prostate significant cancer |
| Date of disclosure of the study information | 2020/11/17 |
| Last modified on | 2020/11/17 08:05:05 |
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Basic information
Public title
Evaluation of the new prostate biopsy strategy for the detection of the prostate significant cancer
Acronym
Evaluation of the new prostate biopsy strategy for the detection of the prostate significant cancer
Scientific Title
Evaluation of the new prostate biopsy strategy for the detection of the prostate significant cancer
Scientific Title:Acronym
Evaluation of the new prostate biopsy strategy for the detection of the prostate significant cancer
Region
| Japan |
Condition
Condition
Prostate cancer suspected
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether a new prostate biopsy strategy contributes to the improvement of the detection accuracy of prostate significant cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of significant cancer in prostatectomy specimens
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.Person whose serum PSA level of 20ng/ml or less.
2.Person who can undergo a transrectal prostate biopsy.
3.Person who has been diagnosed prostate cancer by transrectal biopsy and have undergone radical prostatectomy.
4.Person who agree with informed consent.
Key exclusion criteria
1.Person who have difficulty inserting a transrectal ultrasound probe due to anal stenosis.
2.Person who are regarded as inappropriate for the study by the researcher.
Target sample size
200
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 | Taro |
| Middle name | |
| Last name | Higure |
Organization
Tokai University
Division name
School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
t_higure0415@yahoo.co.jp
Sponsor or person
Institute
Tokai University
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
0463-93-1121
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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will evaluate the significant cancer detection of the biopsy using whole-gland specimen.
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2020 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048023
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
