Multiomics Biomarkers for Urolithiasis

Recruiting

• Conditions: Urolithiasis

• Registration Number: NCT05452291
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This is a prospective case series study. To compare urine sample of recurrent stone-formers and non-stone former by multiomics approach to identify potential markers for stone recurrence.

Detailed Description

A total of 100 Chinese patients with history of recurrent urinary stone and no history of urinary stone disease (control) will be recruited for the study.

Urine will be saved for multiomics analysis, including metabolomics, proteomics, etc. Thereafter, integrated multiomics calculation of recurrent stone can be studied for the differentiation of recurrent stone former and non-stone former.

After completing the preliminary and screening experiments, a large validation cohort (1000 Chinese patients with history of recurrent urinary stone) will be carried out. The patients will then be follow-up in clinic for at least 3 years, with minimum annual review and imaging to detect for any stone recurrence, as defined as increase in stone size and number, or symptomatic stone events. Targeted biomarkers measurement, based on part 1 result, will be done and the result will be used to correlated with the clinical outcomes of stone recurrence.

Study Timeline

• Study Start: 2022-05-27
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-21
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients with history of recurrent urinary stone
• Age greater than or equal to 18 years old
• Have more than 2 episodes of radio-opaque stone disease (bilateral stones were counted as two episode)

Patients with no history of urinary stone disease

• Age greater than or equal to 18 years old
• With no history of urinary calculi, from history and imaging.

Exclusion criteria:

• Patient refused or unable to provide consent for the study
• Patient with active urinary infection
• Patient with radiolucent stone or infective stone
• Patients with no history of urinary stone disease (for control group)
• Patient refused or unable to provide consent for the study
• Patient with active urinary infection

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Level of urinary metabolomics by multiomics approach in non-stone former	every year up to 3 year	Patient will be reviewed with urine collection for the level of urinary metabolomics including metabolomics and proteomics by multiomics analysis every year up to 3 years
Change of Level of urinary proteomics by multiomics approach in recurrent stone-formers	every year up to 3 year	Patient will be reviewed with urine collection for the level of urinary metabolomics including metabolomics and proteomics by multiomics analysis and there will be radiological imaging annually to check if there is any suspect stone every year up to 3 years

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong