Multiomics Biomarkers for Urolithiasis

NCT ID: NCT05452291

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-27

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Urolithiasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chi Fai NG

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chi Fai NG, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Chi Fai NG, MD

Role: CONTACT

Facility Contacts

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Chi Fai NG, MD

Role: primary

References

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Singal RK, Denstedt JD. Contemporary management of ureteral stones. Urol Clin North Am. 1997 Feb;24(1):59-70. doi: 10.1016/s0094-0143(05)70354-2.

Reference Type BACKGROUND
PMID: 9048852 (View on PubMed)

Netto Junior N, Claro JF, Ferreira U, Lemos GC. Lumbar ureteric stones: which is the best treatment? Urology. 1991 Nov;38(5):443-6. doi: 10.1016/0090-4295(91)80234-x.

Reference Type BACKGROUND
PMID: 1949455 (View on PubMed)

Wong MY, Li MK, Foo KT. Extracorporeal shockwave lithotripsy using Storz Modulith SL20--the Singapore General Hospital experience. Ann Acad Med Singap. 1993 Nov;22(6):905-7.

Reference Type BACKGROUND
PMID: 8129354 (View on PubMed)

Carr LK, D'A Honey J, Jewett MA, Ibanez D, Ryan M, Bombardier C. New stone formation: a comparison of extracorporeal shock wave lithotripsy and percutaneous nephrolithotomy. J Urol. 1996 May;155(5):1565-7. doi: 10.1016/s0022-5347(01)66127-5.

Reference Type BACKGROUND
PMID: 8627823 (View on PubMed)

Segura JW, Preminger GM, Assimos DG, Dretler SP, Kahn RI, Lingeman JE, Macaluso JN Jr. Ureteral Stones Clinical Guidelines Panel summary report on the management of ureteral calculi. The American Urological Association. J Urol. 1997 Nov;158(5):1915-21. doi: 10.1016/s0022-5347(01)64173-9.

Reference Type BACKGROUND
PMID: 9334635 (View on PubMed)

Yamada K, Tanokura M, Kawano Y. High-energy phosphate turnover in muscle contraction: time-resolved 31P NMR studies. Prog Clin Biol Res. 1989;315:185-95. No abstract available.

Reference Type BACKGROUND
PMID: 2508132 (View on PubMed)

Kamihira O, Ono Y, Katoh N, Yamada S, Mizutani K, Ohshima S. Long-term stone recurrence rate after extracorporeal shock wave lithotripsy. J Urol. 1996 Oct;156(4):1267-71.

Reference Type BACKGROUND
PMID: 8808851 (View on PubMed)

Eisner BH, Goldfarb DS. A nomogram for the prediction of kidney stone recurrence. J Am Soc Nephrol. 2014 Dec;25(12):2685-7. doi: 10.1681/ASN.2014060631. Epub 2014 Aug 7. No abstract available.

Reference Type BACKGROUND
PMID: 25104802 (View on PubMed)

Schmid M, Dalela D, Tahbaz R, Langetepe J, Randazzo M, Dahlem R, Fisch M, Trinh QD, Chun FK. Novel biomarkers of acute kidney injury: Evaluation and evidence in urologic surgery. World J Nephrol. 2015 May 6;4(2):160-8. doi: 10.5527/wjn.v4.i2.160.

Reference Type BACKGROUND
PMID: 25949930 (View on PubMed)

Alexandroff AB, Jackson AM, Chisholm GD, James K. Cytokine modulation of epidermal growth factor receptor expression on bladder cancer cells is not a major contributor to the antitumour activity of cytokines. Eur J Cancer. 1995 Nov;31A(12):2059-66. doi: 10.1016/0959-8049(95)00210-3.

Reference Type BACKGROUND
PMID: 8562166 (View on PubMed)

Balbay D, Ozen H, Ozkardes H, Barut A, Bakkaloglu M, Tasar C, Remzi D. Detection of urinary interleukin-2, interleukin-2 receptor, and tumor necrosis factor levels in patients with superficial bladder tumors after intravesical BCG immunotherapy. Urology. 1994 Feb;43(2):187-90. doi: 10.1016/0090-4295(94)90042-6.

Reference Type BACKGROUND
PMID: 8116114 (View on PubMed)

Shum DK, Gohel MD, Tam PC. Hyaluronans: crystallization-promoting activity and HPLC analysis of urinary excretion. J Am Soc Nephrol. 1999 Nov;10 Suppl 14:S397-403.

Reference Type BACKGROUND
PMID: 10541272 (View on PubMed)

Other Identifiers

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CRE-2022.093

Identifier Type: -

Identifier Source: org_study_id

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