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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042475
Receipt No. 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

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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
Email 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
Email t_higure0415@yahoo.co.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048023

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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