Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:25 AM
Study NCT ID:
NCT07328932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study to Develop a Model to Identify Uric Acid Urinary Tract Stones Using CT and Lab Tests
Sponsor:
Jian Zhuo
Organization:
Study Overview
Official Title:
Development of a Precision Classification Model for Uric Acid Urinary Stones Based on Multimodal Parameters: A Multicenter Observational Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UAS-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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IIT2025-087 | OTHER_GRANT | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | View |