Urine Biomarker for Stone Recurrence

NCT04354181 | Completed

• 1 other identifier: CRE- 2020.058
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the advent of treating stones with Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous nephrolithotomy (PCNL), the recurrence rate for renal stones remains high and this may be due to poor compliance of patients with dietary and fluid advice, age, metabolic abnormalities, medicines and the formation of "new stones" from clinically insignificant residual fragments (CIRF). Though some patients become stone-free after ESWL/PCNL or open surgeries, the majority develop "new stones" and it is difficult to predict when these stones will recur until either they have imaging perform or they developed symptoms. However, the use of regular imaging for monitoring will be costly and involve radiation exposure. Therefore, a diagnostic tool is needed to enable the clinician and/or patient to monitor for stone recurrence. In the previous studies, some urine markers were identified that are related to stone formation. The relationship of these urine markers with the recurrence of renal stone will be further explore in this study. Also, potential markers that could predict stone recurrence will be identified, and hence earlier intervention could be offered to patients.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• Investigate the time points at which recurrent stone-formers should be monitored over the longitudinal study period and relate biomarker changes to clinical signs and data.

  Patient will be reviewed with early morning urine collection for a complete urinalysis and biomarkers measurement every three months. The inflammatory cytokine expression of RNA retrieved from patient urine will be assessed. There will be radiological testing to check if there is any suspect stone.

  up to 24 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history of radio-opaque urinary calculi with treatment performed (including spontaneous passage) and now stone free.

You may qualify if:

• Adult Chinese male patients with age \> 18 years old
• History of radio-opaque urinary calculi with treatment performed (including spontaneous passage) and now stone free.

You may not qualify if:

• Patient refused or unable to provide consent for the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

about 100 cc urine will be collected for the measurement of Biomarkers

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

Study Design

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

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 21, 2020
• Study Start: July 24, 2020
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

HK (1)