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Active, not recruitingNCT07328932UAS-ModelUpdated Jan 9, 2026

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

An observational study in Urinary Tract Stones, sponsored by Jian Zhuo. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Jian Zhuo · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,650
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Tract Stones

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Keywords

  • Uric acid stones
  • Urinary tract stones
  • Computed tomography
  • Multimodal parameters
  • Prediction model
03

In context

Urinary Calculi

94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.

This study's planned enrollment of 1,650 is above the median of 200 across 31 observational studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

This is the only study on the registry with Jian Zhuo as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of adult patients with urinary tract stones who undergo surgical treatment at participating centers. Eligible participants include patients with kidney, ureteral, bladder, or urethral stones, with available clinical information, laboratory test results, computed tomography imaging, and postoperative stone composition analysis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,650 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Uric Acid Urinary Stones

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

    Other: No intervention (observational study)

  • Non-Uric Acid Urinary Stones

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

    Other: No intervention (observational study)

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.

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What researchers measure

Primary outcomes

  1. Accuracy of multimodal model for identifying uric acid urinary stones.

    The 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.

    Time frame: Perioperatively

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Study locations

1 site
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References and documents

Publications

  • Bultitude M, Smith D, Thomas K. Contemporary Management of Stone Disease: The New EAU Urolithiasis Guidelines for 2015. Eur Urol. 2016 Mar;69(3):483-4. doi: 10.1016/j.eururo.2015.08.010. Epub 2015 Aug 21. No abstract available. PubMed 26304503 ↗
  • Mandel NS, Mandel IC, Kolbach-Mandel AM. Accurate stone analysis: the impact on disease diagnosis and treatment. Urolithiasis. 2017 Feb;45(1):3-9. doi: 10.1007/s00240-016-0943-0. Epub 2016 Dec 3. PubMed 27915396 ↗
  • Zeng G, Mai Z, Xia S, Wang Z, Zhang K, Wang L, Long Y, Ma J, Li Y, Wan SP, Wu W, Liu Y, Cui Z, Zhao Z, Qin J, Zeng T, Liu Y, Duan X, Mai X, Yang Z, Kong Z, Zhang T, Cai C, Shao Y, Yue Z, Li S, Ding J, Tang S, Ye Z. Prevalence of kidney stones in China: an ultrasonography based cross-sectional study. BJU Int. 2017 Jul;120(1):109-116. doi: 10.1111/bju.13828. Epub 2017 Mar 21. PubMed 28236332 ↗
  • Chew BH, Wong VKF, Halawani A, Lee S, Baek S, Kang H, Koo KC. Development and external validation of a machine learning-based model to classify uric acid stones in patients with kidney stones of Hounsfield units < 800. Urolithiasis. 2023 Sep 30;51(1):117. doi: 10.1007/s00240-023-01490-y. PubMed 37776331 ↗
  • Wang Z, Yang G, Wang X, Cao Y, Jiao W, Niu H. A combined model based on CT radiomics and clinical variables to predict uric acid calculi which have a good accuracy. Urolithiasis. 2023 Feb 6;51(1):37. doi: 10.1007/s00240-023-01405-x. PubMed 36745218 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared because the study involves multicenter clinical data containing sensitive personal and imaging information. Data sharing is restricted by institutional policies, ethical approvals, and data protection regulations.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Aug 2027, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2025
First posted
Jan 9, 2026
StartActual
Oct 20, 2025
Primary completionEst.
Aug 20, 2027
CompletionEst.
Oct 20, 2027
Last update
Jan 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07328932
Lead sponsor
Jian Zhuo
Responsible party
Jian Zhuo (Principal Investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Sponsor-investigator
First posted
Jan 9, 2026
Start date
Oct 20, 2025
Primary completion
Aug 20, 2027 (estimated)
Completion
Oct 20, 2027 (estimated)
Last update
Jan 9, 2026

Study contacts

Jian Zhuo, PhD
principal investigator · Department of Urology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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