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Multiomics Biomarkers for Urolithiasis

Exploring Multiomics Biomarkers for Urolithiasis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05452291
Enrollment
1200
Registered
2022-07-11
Start date
2022-05-27
Completion date
2027-12-31
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

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.

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Level of urinary metabolomics by multiomics approach in non-stone formerevery year up to 3 yearPatient 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-formersevery year up to 3 yearPatient 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

Countries

Hong Kong

Contacts

Primary ContactChi Fai NG, MD
ngcf@surgery.cuhk.edu.hk35052625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026