UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009755 |
|---|---|
| Receipt number | R000011430 |
| Scientific Title | Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy and molecular and microbiological analysis of rectal Escherichia coli with quinolone-resistance |
| Date of disclosure of the study information | 2013/01/11 |
| Last modified on | 2019/01/16 09:09:38 |
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Basic information
Public title
Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy and molecular and microbiological analysis of rectal Escherichia coli with quinolone-resistance
Acronym
Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy
Scientific Title
Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy and molecular and microbiological analysis of rectal Escherichia coli with quinolone-resistance
Scientific Title:Acronym
Clinical efficacy of prevention against infectious complication after transrectal prostate biopsy
Region
| Japan |
Condition
Condition
suspected prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To prevent the occurrence of acute bacterial prostatitis after transrectal prostate biopsy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevention of acute bacterial prostatitis
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
quinolone-resistant E coli or not
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
suspected prostate cancer
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Takahashi |
Organization
Sapporo Medical University
Division name
School of Medicine, Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
stakahas@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Takahashi |
Organization
Sapporo Medical University
Division name
School of Medicine, Department of Urology
Zip code
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
stakahas@sapmed.ac.jp
Sponsor or person
Institute
Department of Urology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Sapporo Medical University School of Medicine
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
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
| 2013 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011430
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
