Clinical trial NCT05452291: Multiomics Biomarkers for Urolithiasis
Official title: Exploring Multiomics Biomarkers for Urolithiasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urolithiasis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects have more than 2 episodes of radio-opaque stone disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Level of urinary metabolomics by multiomics approach in non-stone former
timeFrame: every year up to 3 year
measure: Change of Level of urinary proteomics by multiomics approach in recurrent stone-formers
timeFrame: every year up to 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
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