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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038610
Receipt No. R000043957
Scientific Title Identification of correlates of noturnal polyuria, with special attention to metabolomics
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/18

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Basic information
Public title Identification of correlates of noturnal polyuria, with special attention to metabolomics
Acronym Metabolomics approach for nocturnal polyuria
Scientific Title Identification of correlates of noturnal polyuria, with special attention to metabolomics
Scientific Title:Acronym Metabolomics approach for nocturnal polyuria
Region
Japan

Condition
Condition nocturnal polyuria
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify metabolites in blood and urine, correlating to nocturnal polyuria, by comparing diurnal with nocturnal metabolites
Basic objectives2 Others
Basic objectives -Others To identify metablites in blood and urine, correlating to nocturnal polyuria, by comparing those in patients with nocturnal polyuria and those in controls, who have no nocturia.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Identification of metabolites correlating to nocturnal polyuria
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) ECOG performance status: 0~1
2) Pts., who can perform 3-day frequency-volume charts
Key exclusion criteria 1) Pts., the contents of whose peroral medicine change within 4 weeks.
2) Pts., who undergo surgical intervention within 4 weeks.
3) Pts., who perorally receive diuretics or anti-diuretics, such as vasopression or its analogue.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Yoshimura
Organization Shizuoka General Hospital
Division name urology
Zip code 420-8527
Address 4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL 0542476111
Email ky7527@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Yoshimura
Organization Shizuoka General Hospital
Division name urology
Zip code 420-8527
Address 4-27-1, Kitaando, Aoi-ku, Shizuoka
TEL 0542476111
Homepage URL
Email ky7527@kuhp.kyoto-u.ac.jp

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization Shizuoka Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee of Shizuoka General Hospital
Address 4-27-1, Kitaando, Aoi-ku, Shizuoka
Tel 0542476111
Email akiko-mochizuki@shizuoka-pho.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
2019 Year 12 Month 01 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
2019 Year 07 Month 02 Day
Date of IRB
2019 Year 09 Month 10 Day
Anticipated trial start date
2019 Year 09 Month 18 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Frequency volume charts, nocturnal and early morning motabolomics analyses using blood and urine samples, questionnaire for LUTS, measurement of renal blood flow, ABI, PMV, RR interval, examination of respiratory function, measurement of moisture quantity in the body

Management information
Registered date
2019 Year 11 Month 18 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043957

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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