UMIN-CTR Clinical Trial

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
Email	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
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	Hirosaki University Graduate School of Medicine
Address	5 Zaifu-chou
Tel	0172-33-5111
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038740