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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039542
Receipt No. R000045073
Scientific Title Retrospective study of prostate biopsy in patients with suspicion of prostate cancer
Date of disclosure of the study information 2020/02/20
Last modified on 2020/08/21

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Basic information
Public title Retrospective study of prostate biopsy in patients with suspicion of prostate cancer
Acronym Retrospective study of prostate biopsy on suspicion of prostate cancer
Scientific Title Retrospective study of prostate biopsy in patients with suspicion of prostate cancer
Scientific Title:Acronym Retrospective study of prostate biopsy on suspicion of prostate cancer
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical factors and positive rate of prostate cancer in patients with high level of PSA
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes positive rate of prostate biopsy and associated clinical factors
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
85 years-old >=
Gender Male
Key inclusion criteria patients who are not diagnosed as prostate cancer previously
patients undergone prostate biopsies between Jan/1st/2016 and Dec/31/2016, between PSA levels 5 to 19.9 ng/mL
Key exclusion criteria patients who had been diagnosed as prostate cancer
patients with PSA level, PSA<5, >=20 ng/mL
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Hiroji
Middle name
Last name Uemura
Organization Yokohama City University Medical Center
Division name Department of Urology & Renal Transplantation
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
TEL 045-261-5656
Email hu0428@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Hiroji
Middle name
Last name Uemura
Organization Yokohama City University Medical Center
Division name Department of Urology & Renal Transplantation
Zip code 232-0024
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
TEL 045-261-5656
Homepage URL
Email hu0428@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Yokohama City University Medical Center
Address 4-57, Urafune-cho, Minami-ku, Yokohama, 232-0024
Tel 045-261-5656
Email hu0428@yokohama-cu.ac.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 02 Month 20 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 1000
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 No longer recruiting
Date of protocol fixation
2019 Year 05 Month 04 Day
Date of IRB
2019 Year 06 Month 19 Day
Anticipated trial start date
2019 Year 06 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Using the data of 977 cases from 6 institutes, retrospective analysis was performed. We investigated the rates of biopsy positive and negative, with or without anti-hypertension (includign ARBs or non-ARBs), PSA trends during follow-up after biopsy (negative case), and the results of repeated biopsy. Retrospective investigation in the cohort with PSA 20 or more has been added.

Management information
Registered date
2020 Year 02 Month 20 Day
Last modified on
2020 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045073

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/03/01 200308前立腺癌 後ろ向き試験(20210301).xlsx


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