Multiomics Biomarkers for Urolithiasis

NCT05452291 | Recruiting

• 1 other identifier: CRE-2022.093
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (2)

• Change of Level of urinary metabolomics by multiomics approach in non-stone former

  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

  every year up to 3 year

• Change of Level of urinary proteomics by multiomics approach in recurrent stone-formers

  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

  every year up to 3 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects have more than 2 episodes of radio-opaque stone disease

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (12)

• 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.

  PMID: 9048852 BACKGROUND

• 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.

  PMID: 1949455 BACKGROUND

• 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.

  PMID: 8129354 BACKGROUND

• 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.

  PMID: 8627823 BACKGROUND

• 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.

  PMID: 9334635 BACKGROUND

• 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.

  PMID: 2508132 BACKGROUND

• 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.

  PMID: 8808851 BACKGROUND

• 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.

  PMID: 25104802 BACKGROUND

• 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.

  PMID: 25949930 BACKGROUND

• 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.

  PMID: 8562166 BACKGROUND

• 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.

  PMID: 8116114 BACKGROUND

• 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.

  PMID: 10541272 BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai NG, MD

CONTACT

35052625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 11, 2022
• Study Start: May 27, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)