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Multicenter Study to Develop a Model to Identify Uric Acid Urinary Tract Stones Using CT and Lab Tests

Development of a Precision Classification Model for Uric Acid Urinary Stones Based on Multimodal Parameters: A Multicenter Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07328932
Acronym
UAS-Model
Enrollment
1650
Registered
2026-01-09
Start date
2025-10-20
Completion date
2027-10-20
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Stones

Keywords

Uric acid stones, Urinary tract stones, Computed tomography, Multimodal parameters, Prediction model

Brief summary

Urinary tract stones are a common condition affecting the kidney, ureter, bladder, and urethra. Uric acid stones represent an important subtype of urinary stones and require different prevention and treatment strategies compared with other stone types. However, accurate identification of uric acid stones before treatment remains challenging in routine clinical practice. This multicenter observational study aims to develop and validate a precision classification model to distinguish uric acid urinary tract stones from non-uric acid stones using multimodal parameters. These parameters include patients' clinical characteristics, laboratory test results, and computed tomography (CT) imaging features. Patients undergoing surgical treatment for urinary tract stones at participating centers will be enrolled. Stone composition determined by infrared spectroscopy after surgery will be used as the reference standard. By integrating clinical, laboratory, and imaging data, this study seeks to establish a practical and reliable model to improve the classification of uric acid stones and support individualized clinical management.

Detailed description

This is a multicenter observational study designed to develop and validate a precision classification model for uric acid urinary tract stones based on multimodal parameters. The study will be conducted at multiple hospitals in China and will include adult patients undergoing surgical treatment for urinary tract stones involving the kidney, ureter, bladder, or urethra. Clinical data, laboratory parameters (including serum and urine biochemical indices), and CT imaging features will be collected before treatment according to standardized protocols. Stone composition determined by postoperative infrared spectroscopy will serve as the reference standard, with uric acid stones defined based on established compositional criteria. The study population will be divided into training and validation cohorts. Multivariable statistical modeling will be used to identify independent predictors of uric acid stones and to construct a prediction model. Model performance will be evaluated using discrimination, calibration, and clinical utility analyses. The results of this study are expected to provide a clinically applicable tool for more accurate classification of uric acid urinary tract stones, which may facilitate individualized prevention strategies and treatment decision-making in patients with urinary stone disease.

Interventions

OTHERNo intervention (observational study)

This is an observational cross-sectional study. Participants are not assigned to any intervention as part of the study. All clinical management, imaging examinations, and laboratory tests are performed as part of routine clinical care.

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
CollaboratorOTHER
Jian Zhuo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with a confirmed diagnosis of urinary tract stones, including kidney stones, ureteral stones, bladder stones, or urethral stones. * Patients who undergo surgical treatment for urinary tract stones at participating centers during the study period, including ureteroscopy or flexible ureteroscopy lithotripsy, percutaneous nephrolithotomy, pyelolithotomy or ureterolithotomy, or transurethral cystolithotripsy. * Patients whose stone composition is determined by postoperative infrared spectroscopy analysis.

Exclusion criteria

* Patients with multiple stones or stones located at multiple sites, such as multiple renal stones or concomitant kidney and ureteral stones, to avoid discrepancies between computed tomography measurements of the target stone and stone composition analysis. * Pregnant or breastfeeding women. * Patients younger than 18 years of age.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of multimodal model for identifying uric acid urinary stones.PerioperativelyThe primary outcome is the diagnostic performance of a multimodal classification model for identifying uric acid urinary tract stones. The model integrates clinical characteristics, laboratory parameters, and computed tomography imaging features. Stone composition determined by postoperative infrared spectroscopy is used as the reference standard. Model performance will be evaluated using discrimination metrics such as the area under the receiver operating characteristic curve.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026