Comparison of Different Methods for Measuring Urinary Oxalate and Citrate: An Observational Study

NCT06916559 | Completed

• 1 other identifier: ES-2024-242-01
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to compare three different laboratory methods for measuring urine oxalate and citrate concentrations. The primary objective is to evaluate whether an improved High-Performance Liquid Chromatography (HPLC) method-using a novel derivatization reagent-can achieve similar accuracy to the gold standard Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) while offering advantages in cost, speed, and ease of use in routine clinical settings. The study will involve the collection of morning urine samples from both healthy volunteers and patients with urolithiasis (urinary stones). Each urine sample will be tested using the following three methods:

1. 1.Modified High-Performance Liquid Chromatography (HPLC): This method builds on traditional HPLC technology by incorporating a novel derivatization reagent to enhance the sensitivity and accuracy of detecting oxalate and citrate. The improved HPLC method is designed to be less time-consuming and more cost-effective, which could make it a viable option for regular clinical use.
2. 2.Ion Chromatography (IC): Widely used in many hospital laboratories, the IC method detects urine oxalate and citrate without the need for a derivatization step. While this method is straightforward and convenient, its sensitivity and accuracy are expected to be lower compared to LC-MS/MS and the modified HPLC method.
3. 3.Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS): LC-MS/MS is currently considered the gold standard for measuring urine oxalate and citrate due to its high sensitivity and specificity. However, the method requires expensive equipment and involves complex procedures, limiting its routine application in most clinical laboratories.

Conditions

Hyperuricosuria; Hypocitraturia

Outcome Measures

Primary Outcomes (1)

• Comparison of Uric Acid Measurements from Three Methods

  The primary outcome is to compare the uric acid measurement results obtained from three analytical methods: modified High-Performance Liquid Chromatography (HPLC) using a novel derivatization reagent, Ion Chromatography (IC), and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). This outcome will be evaluated by determining the mean differences, 95% confidence intervals, and correlations among the three methods using Bland-Altman analysis and linear regression. The goal is to assess whether the modified HPLC method can reliably reflect uric acid levels comparable to the LC-MS/MS gold standard.

  Baseline sample analysis, with all measurements completed within 24 hours of sample collection.

Secondary Outcomes (1)

• Comparison of Urinary Citrate Measurements from Three Methods

  Baseline sample analysis, with all measurements completed within 24 hours of sample collection.

Study Arms (2)

Patients with Urolithiasis

Healthy people

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational study will enroll adult participants from two groups: patients with urolithiasis (specifically those exhibiting hyperuricosuria and hypocitraturia) and healthy volunteers without any history of urinary stone disease or related metabolic disorders. The study aims to compare urinary uric acid and citrate measurements obtained using three different analytical methods.

You may qualify if:

• Imaging evidence indicating the presence of urinary stones (stone patient group).
• Imaging evidence indicating the absence of urinary stones (control group).

You may not qualify if:

• \. Patients who are unable to understand or complete the study documentation.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Department of Urology and Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510230, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: March 1, 2025
• Primary Completion: March 15, 2025
• Study Completion: April 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)