Multiomics Biomarkers for Urolithiasis

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05452291
Collaborator
(none)
1,200
1
67.2
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Exploring Multiomics Biomarkers for Urolithiasis
    Actual Study Start Date :
    May 27, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2026
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince of Wales Hospital Shatin Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chi Fai NG, Professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05452291
    Other Study ID Numbers:
    • CRE-2022.093
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Jul 11, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2022