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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033964
Receipt No. R000038740
Scientific Title Development and validation of a nomogram to predict the possibility of urolithiasis
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/31

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Basic information
Public title Development and validation of a nomogram to predict the possibility of urolithiasis
Acronym Development and validation of a nomogram to predict the possibility of urolithiasis
Scientific Title Development and validation of a nomogram to predict the possibility of urolithiasis
Scientific Title:Acronym Development and validation of a nomogram to predict the possibility of urolithiasis
Region
Japan

Condition
Condition urolithiasis
Classification by specialty
Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop and validate a nomogram that predicts individual probability of urolithiasis
Basic objectives2 Others
Basic objectives -Others To develop and validate a nomogram that predicts individual probability of urolithiasis
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Develop a nomogram that predicts individual probability of urolithiasis
Key secondary outcomes Validate a nomogram that predicts individual probability of urolithiasis

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
10 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Control: healthy volunteer or healthy subject without suspicious of urolothiasis
Key exclusion criteria Patients with severe comorbidities that could not include for the sudy.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code
Address 5 zaifuchou, Hirosaki, Japan
TEL 0172395091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code
Address 5 zaifuchou, Hirosaki, Japan
TEL 0172395091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 09 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We retrospectively analyze patients with urinary stone and non-stone individuals.
Thereafter, prospective observational study will be conduct to validate the feasibility of the nomogram

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038740

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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