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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-20

Study Completion Date

2027-10-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Stones

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Uric Acid Urinary Stones

Patients with urinary tract stones classified as uric acid stones based on postoperative infrared spectroscopy analysis.

No intervention (observational study)

Intervention Type OTHER

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.

Non-Uric Acid Urinary Stones

Patients with urinary tract stones classified as non-uric acid stones based on postoperative infrared spectroscopy analysis.

No intervention (observational study)

Intervention Type OTHER

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.

Interventions

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No 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No