UrolithiasisNCT05452291
Multiomics Biomarkers for Urolithiasis
An observational study of Urolithiasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- How many people
- 3 participants
- Where
- 1 siteHong Kong
- Study dates
- 27 May 2022to 21 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects have more than 2 episodes of radio-opaque stone disease
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Multiomics Biomarkers for Urolithiasis
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.
- Conditions
- Urolithiasis
- Medical subject headings
- Urolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: every year up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start27 May 2022
- Primary completion31 Dec 2024
- Study completion21 Jan 2025
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452291
- Sponsor's protocol ID
- CRE-2022.093
- Status last verified
- Oct 2026
- First submitted
- 27 Jun 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 9048852Netto 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 1949455Wong 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 8129354Carr 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 8627823Segura 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 9334635Yamada 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 2508132Kamihira 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 8808851Eisner 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 25104802Schmid 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 25949930Alexandroff 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 8562166Balbay 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 8116114Shum 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Multiomics Biomarkers for Urolithiasis
- ClinicalTrials.gov ID
- NCT05452291
- Acronym / sponsor ID
- CRE-2022.093
- Conditions
- Urolithiasis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects have more than 2 episodes of radio-opaque stone disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Level of urinary metabolomics by multiomics approach in non-stone former
Time frame: 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
Change of Level of urinary proteomics by multiomics approach in recurrent stone-formers
Time frame: 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
Results and safety
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 9048852Singal 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.
- Background: PubMed 1949455Netto 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.
- Background: PubMed 8129354Wong 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.
- Background: PubMed 8627823Carr 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.
- Background: PubMed 9334635Segura 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.
- Background: PubMed 2508132Yamada 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.
- Background: PubMed 8808851Kamihira 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.
- Background: PubMed 25104802Eisner 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.
- Background: PubMed 25949930Schmid 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.
- Background: PubMed 8562166Alexandroff 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.
- Background: PubMed 8116114Balbay 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.
- Background: PubMed 10541272Shum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Level of urinary metabolomics by multiomics approach in non-stone former (time frame: every year up to 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452291, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.