UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033964 |
|---|---|
| Receipt number | 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 | 2022/12/06 12:51:33 |
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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 | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
5 zaifuchou, Hirosaki, Japan
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
5 zaifuchou, Hirosaki, Japan
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
Hirosaki University Graduate School of Medicine
Address
5 Zaifu-chou
Tel
0172-33-5111
rinri@hirosaki-u.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
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32147889/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32147889/
Number of participants that the trial has enrolled
1305
Results
we developed and validated the STone Episode Prediction nomogram that can predict a potential candidate for an episode of urolithiasis. This nomogram might be beneficial for the first step in stone screening in individuals with lifestyle-related diseases.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Objectives: To develop and validate a nomogram predicting the occurrence of a stone episode, given the lack of such predicting risk tools for urolithiasis.
Participant flow
Methods: We retrospectively analyzed 1305 patients with urolithiasis and 2800 community-dwelling individuals who underwent a comprehensive health survey. The STone Episode Prediction nomogram was created based on data from the medical records of 600 patients with urolithiasis and 1300 controls, and was validated using a different population of 705 patients with urolithiasis and 1500 controls. Logistic regression analysis was used to construct a model to predict the potential candidate for a stone episode.
Adverse events
none
Outcome measures
The predictive ability of the model was evaluated using the results of the area under the receiver operating characteristics curve (area under the curve).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
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
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038740
