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TerminatedNCT05452291Updated Oct 22, 2026

Multiomics Biomarkers for Urolithiasis

An observational study in Urolithiasis, sponsored by Chinese University of Hong Kong. Terminated at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Chinese University of Hong Kong · Observational

Why this study was terminated
Funding issues
Updated Oct 22, 2026Now TerminatedStudy completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urolithiasis

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03

In context

Urolithiasis

253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.

This study's enrollment of 3 is below the median of 150 across 65 observational studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: every year up to 3 year

  2. 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

    Time frame: every year up to 3 year

07

Study locations

1 site
  • Prince of Wales Hospital
    Shatin, Hong Kong
08

References and documents

Publications

  • 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. PubMed 9048852 ↗
  • 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. PubMed 1949455 ↗
  • 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. PubMed 8129354 ↗
  • 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. PubMed 8627823 ↗
  • 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. PubMed 9334635 ↗
  • 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. PubMed 2508132 ↗
  • 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. PubMed 8808851 ↗
  • 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. PubMed 25104802 ↗
  • 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. PubMed 25949930 ↗
  • 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. PubMed 8562166 ↗
  • 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. PubMed 8116114 ↗
  • 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. PubMed 10541272 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from May 2022 to primary completion in Dec 2024, 31 months.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2027 → Jan 2025, on Oct 22, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2022
First posted
Jul 11, 2022
StartActual
May 27, 2022
Primary completionActual
Dec 31, 2024
CompletionActual
Jan 21, 2025was Dec 2027
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Terminated Funding issues
changed Oct 22, 2026
Study completion
Dec 31, 2027→Jan 21, 2025 (actual)
Oct 22, 2026
Enrollment
1200 (estimated)→3 (actual)
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Recruiting→Terminated
    Why stopped Funding issues
    Study completion Dec 31, 2027→Jan 21, 2025 (now actual)
    Enrollment 1200 (estimated)→3 (actual)
    + 5 other changes: verification date, responsible party, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05452291
Responsible party
NG Chi Fai (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Jul 11, 2022
Start date
May 27, 2022
Primary completion
Dec 31, 2024
Completion
Jan 21, 2025
Last update
Oct 22, 2026

Study contacts

Chi Fai NG, MD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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