HyperuricosuriaComparison ofNCT06916559
Comparison of Different Methods for Measuring Urinary Oxalate and Citrate: An Observational Study
An observational study of Hyperuricosuria and Hypocitraturia, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hyperuricosuria, Hypocitraturia
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Imaging evidence indicating the presence of urinary stones (stone patient group).
- Imaging evidence indicating the absence of urinary stones (control group).
Who cannot join
- 1. Patients who are unable to understand or complete the study documentation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology and Guangdong Key Laboratory of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
About this study
Official title: Novel Derivatization-Based HPLC for Urinary Oxalate and Citrate: A Superior Clinical Alternative to Ion Chromatography
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:
Read more
- 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.
- 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.
- 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.
Participants will provide urine samples, which will be divided and analyzed using all three methods simultaneously. The study will assess the correlation and consistency between the methods, with a particular focus on comparing the modified HPLC method to LC-MS/MS. Statistical analyses, including Bland-Altman analysis and linear regression, will be used to determine the agreement between the measurement techniques.
This study is non-interventional and involves only the collection of urine samples, posing minimal risk to participants. Informed consent will be obtained from all participants after they are fully briefed about the study objectives, procedures, and any potential risks. All collected data will be managed confidentially and analyzed rigorously to ensure the reliability of the findings.
If the modified HPLC method demonstrates comparable accuracy to LC-MS/MS, it could provide a more accessible, cost-effective, and timely option for routine clinical measurement of urinary oxalate and citrate. Such an improvement in laboratory diagnostics may support better clinical decision-making in the prevention and management of urinary stone disease, ultimately benefiting patient care.
- Conditions
- Hyperuricosuria, Hypocitraturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Urolithiasis | Not described | |
| Healthy people | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline sample analysis, with all measurements completed within 24 hours of sample collection.
Secondary outcomes (1)
Comparison of Urinary Citrate Measurements from Three Methods
The secondary outcome is to evaluate and compare the urinary citrate concentration results obtained from the three methods: modified HPLC, Ion Chromatography (IC), and LC-MS/MS. The analysis will include calculating mean differences, 95% confidence intervals, and assessing the degree of correlation among the methods using statistical tools such as Bland-Altman plots and linear regression. This outcome will help determine the consistency and reliability of citrate measurements across the different analytical techniques.
Measured: Baseline sample analysis, with all measurements completed within 24 hours of sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Mar 2025
- Primary completion15 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricosuriaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916559
- Sponsor's protocol ID
- ES-2024-242-01
- Acronym
- Comparison of
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Derivatization-Based HPLC for Urinary Oxalate and Citrate: A Superior Clinical Alternative to Ion Chromatography
- ClinicalTrials.gov ID
- NCT06916559
- Acronym / sponsor ID
- Comparison of / ES-2024-242-01
- Conditions
- Hyperuricosuria, Hypocitraturia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Participants will provide urine samples, which will be divided and analyzed using all three methods simultaneously. The study will assess the correlation and consistency between the methods, with a particular focus on comparing the modified HPLC method to LC-MS/MS. Statistical analyses, including Bland-Altman analysis and linear regression, will be used to determine the agreement between the measurement techniques.
This study is non-interventional and involves only the collection of urine samples, posing minimal risk to participants. Informed consent will be obtained from all participants after they are fully briefed about the study objectives, procedures, and any potential risks. All collected data will be managed confidentially and analyzed rigorously to ensure the reliability of the findings.
If the modified HPLC method demonstrates comparable accuracy to LC-MS/MS, it could provide a more accessible, cost-effective, and timely option for routine clinical measurement of urinary oxalate and citrate. Such an improvement in laboratory diagnostics may support better clinical decision-making in the prevention and management of urinary stone disease, ultimately benefiting patient care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Urolithiasis | – | – |
| Healthy people | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Imaging evidence indicating the presence of urinary stones (stone patient group).
- Imaging evidence indicating the absence of urinary stones (control group).
Key exclusion criteria (1 listed)
- 1. Patients who are unable to understand or complete the study documentation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Uric Acid Measurements from Three Methods
Time frame: Baseline sample analysis, with all measurements completed within 24 hours of sample collection.
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.
1 secondary outcome
Comparison of Urinary Citrate Measurements from Three Methods
Time frame: Baseline sample analysis, with all measurements completed within 24 hours of sample collection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperuricosuria and Hypocitraturia, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Uric Acid Measurements from Three Methods (time frame: Baseline sample analysis, with all measurements completed within 24 hours of sample collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.