UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049901 |
|---|---|
| Receipt number | R000056835 |
| Scientific Title | Prospective and retorospective observational study on the usefulness of the UF-5000 urinary leukocyte and urinary bacterial counts for the diagnosis of male urethritis. |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2022/12/26 13:48:53 |
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Basic information
Public title
Prospective and retorospective observational study on the usefulness of the UF-5000 urinary leukocyte and urinary bacterial counts for the diagnosis of male urethritis.
Acronym
Study of the usefulness of the UF-5000 in the diagnosis of male urethritis
Scientific Title
Prospective and retorospective observational study on the usefulness of the UF-5000 urinary leukocyte and urinary bacterial counts for the diagnosis of male urethritis.
Scientific Title:Acronym
Study of the usefulness of the UF-5000 in the diagnosis of male urethritis
Region
| Japan |
Condition
Condition
male urethritis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between leukocyte (mononuclear cell, polynuclear cell) classification by UF-5000 and causative microorganisms of non-gonococcal urethritis, and to help in the diagnosis of male urethritis, especially in the rapid diagnosis of urethritis caused by causative microorganisms that are difficult to detect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the percentage of agreement between the results of each method.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients with suspected urethritis
Patients who can provide a specimen of primary urine, urethral discharge, pharyngeal abrasion, or gargle
Patients who can give consent to participate in this study
Key exclusion criteria
Patients who did not give consent to participate in this study
Patients who refused to participate in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yaduda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo, Hokkaido
TEL
011-611-2111
yasuda7jpe@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16,Chuo-ku,Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Sapporo Medical University School of Medicine
Address
S1 W16,Chuo-ku,Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
| 2022 | Year | 12 | Month | 26 | 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
| 2022 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the correlation between the results of genetic testing for pathogenic microorganisms performed within the scope of usual medical care and the results of genetic testing for pathogenic microorganisms performed at the National Institute of Infectious Diseases.
A 2 x 2 contingency table will be created from the results of leukocyte classification and genetic test measurements and their respective control test results, and Calculate the overall concordance rate, positive concordance rate, negative concordance rate, positive predictive value, and negative predictive value. If there is a discrepancy in the results, the cause of the discrepancy is discussed. The causes of the discrepancies are discussed.
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056835
