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

Jian Zhuo

Status

Active, not recruiting

Conditions

Urinary Tract Stones

Treatments

Other: No intervention (observational study)

Study type

Observational

Funder types

Other

Identifiers

NCT07328932

IIT2025-087 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.