UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029964 |
|---|---|
| Receipt number | R000033764 |
| Scientific Title | The exploration of urinary biomarkers in patients with lower urinary tract dysfunction |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2022/11/18 16:40:00 |
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Basic information
Public title
The exploration of urinary biomarkers in patients with lower urinary tract dysfunction
Acronym
Urinary biomarkers of lower urinary tract dysfunction
Scientific Title
The exploration of urinary biomarkers in patients with lower urinary tract dysfunction
Scientific Title:Acronym
Urinary biomarkers of lower urinary tract dysfunction
Region
| Japan |
Condition
Condition
Lower urinary tract dysfunction
Classification by specialty
| Urology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify novel urinary biomarkers in patients with lower urinary tract dysfunction.
Basic objectives2
Others
Basic objectives -Others
Desease-specific biomarkers in urine
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To identify novel urinary biomarkers in patients with lower urinary tract dysfunction (benign prostatic hyperplasia, overactive bladder, interstitial cystitis, underactive bladder).
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 and Female
Key inclusion criteria
1. Patients with lower urinary tract dysfunction (benign prostatic hyperplasia, overactive bladder, interstitial cystitis, low activity bladder).
2. Normal volunteers who have no lower urinary tract symptoms.
Key exclusion criteria
Person who is considered ineligible by an attending physician.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Otsuka |
| Middle name | |
| Last name | Atsushi |
Organization
Hamamatsu University School of Medicine
Division name
Urology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2306
otsuka@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Otsuka |
Organization
Hamamatsu University School of Medicine
Division name
Urology
Zip code
431-4392
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2306
Homepage URL
otsuka@hama-med.ac.jp
Sponsor or person
Institute
Department of Urology, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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 of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel
053-435-2111
rinri@hama-med.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
浜松医科大学病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 14 | 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
| 2017 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Profiles of urine biomarkers are compared between 200 patients with lower urinary tract dysfunction and approximately 50 healthy controls.
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033764
| 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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