Stone Centre Urine and Serum Bank

Purpose:

The purpose of the Stone Centre Serum and Urine Bank is to provide researchers with large numbers of serum and urine samples from kidney stone patients and controls for study of stone disease detection and treatment, and will take into account different genetic backgrounds, ages, and other patient factors to provide a broad sample size for the study of stone disease The Serum and Urine Bank will undoubtedly be an invaluable tool in the quest to understanding urinary stone disease.

Objective:

The objective of this research is to identify protein species or other compounds responsible for or contributing to kidney stone initiation and propagation.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Stones

Detailed Description

Background:

While great strides have been made in the surgical treatment of kidney stones, the means to identify high-risk patients for the prevention of kidney stones has lagged far behind. Urinary stone disease is a common problem, causes significant disability and sometimes death, and costs society 1.8 billion dollars each year. Therefore, it is important to identify those patients who are at risk or in the process of developing kidney stones and develop procedures which halt and/or prevent stone formation. Unfortunately, the current methods used for identifying such patients are inadequate. Kidney stone patients undergo urine and serum testing to attempt to identify substances that are either in excess or deficit in the body. The levels of these substances are then adjusted with diet modification and/or the use of medication. Often, patients who have corrected their abnormal values via diet or medications or others who have no identifiable risk factors continue to form stones. Clearly, current testing methods used to identify the continuous formation of stones are not enough, largely due to the fact that the causes of this disease are not completely understood.

There exists strong evidence supporting a role for proteins, both in promoting stone formation and in their prevention. Furthermore there may be hereditary factors (i.e. a family history) that may increase the risk of some patients becoming chronic kidney stone formers. This suggests a very complex cause of the disease and emphasizes the need and importance of identifying the genes and proteins involved in formation of stones.

Research Methods:

Urine and serum samples will be collected from study and control groups. Study group will be formed from confirmed kidney stone patients followed until post recovery, and the control group from healthy individuals. Control patients will have no history of kidney stone disease. Control subjects may be asked to undergo a screening renal ultrasound to ensure they are stone free.

If there is ureteral stent placed after surgery in stone patients, once it is removed, it is typically thrown into the garbage. With this study, it will be removed and the surface of the stent will be examined for crystals and adherent proteins. The collected samples will be submitted for SELDI analysis and to measure non-protein components. Each patient's serum sample will also be submitted for protein analysis. Other samples will be stored indefinitely until used. The urine, serum, and ureteral stents obtained in this study will be banked at -80C in a locked, secure area.

Recruitment:

Recruitment of study group will be through the Urology and Stone Clinic in the Diamond Health Care Centre at Vancouver General Hospital and Dr Joel Teichman's Practice at St Paul's Hospitals. Patients will be asked to participate by a urologist (Drs Chew, Teichman, Nigro, Fenster or Paterson) or the research coordinator. Control patients will be matched for age and sex to the study group. They will have no history of stone disease. The consent form will be provided to the participants by one of the investigators or a clinical research coordinator involved in the study. This will occur in one of the urology clinics.

Risks:

The risks involved are minimal; drawing blood can result in possible bleeding, fainting, bruising and infection. Urine collection has minimal risks.

Benefits:

There will not be any direct benefit from taking part in this urine and serum banking. We anticipate that the information gained will benefit others in the future and provide detection and treatment of urinary stone disease. No reimbursements or payments are being offered, as there will be no expenses to the patients as a result of the banking of urine and serum.

Confidentiality:

All samples will be coded to preserve anonymity of the subjects. Once distributed, the samples will be labeled only with the code. At no point in time will the patient identifiers leave the Stone Centre Serum and Urine Bank.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada
      • UBC Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Accepts patients with stone disease and healthy volunteers as controls

Description

Inclusion Criteria:

• Controls: age > 19 and no history of kidney stone disease);
• Study (Stone Patient): Age > 19, radiological evidence indicating presence of a current renal or ureteric stone.

Exclusion Criteria:

• Pregnancy,
• Positive Urine Culture,
• Active cancer,
• Recurrent urinary infections,
• Gross hematuria,
• Inability to provide informed consent,
• Investigator's refusal to include,

• CONTROLS ONLY:

  • Family history of stones,
  • History of stones

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control Group; The control subjects of this study will be asked to undergo renal ultrasound examination, if available, or will be asked to complete a disease history form to determine the presence or lack of a kidney stone. Urine and serum will then be taken for storage until further analysis. Controls will be asked to undergo a screening renal ultrasound to ensure they are stone free, this will take approximately 45 minutes. If the controls are asked to complete the history form, this will not take more than 20 minutes. They will also give a blood and urine sample during this time to bring the total extra time up to at most 60 minutes for controls."
Stone Group; The stone group will undergo standard diagnostic procedures for their condition and recovery process. Serum and urine for storage and analysis will be taken prior to stone treatment and 6 weeks following stone treatment. This will allow for the determination of differences in a stone patient's protein profile while they have their stone and after they are stone free. All patients will be required to have a stone patient metabolic evaluation which includes serum and urine testing. The analysis will focus on the serum and urine sample that they provide. The stone patient will be asked to undergo one extra tube of blood during their preoperative assessment which should only add a few seconds to their visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genetic factors in stone disease	We are to determine the genetic factors that contributes to kidney stone disease from the microbiome analysis of urine and serum samples.	one time sample

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Ben H. Chew, MD, FRCSC, University of British Columbia; Study Director: Ryan Paterson, MD, University of British Columbia; Study Director: Howard Fenster, MD, University of British Columbia; Study Director: Caitlin Dobie, University of British Columbia; Study Director: Dirk Lange, MD, University of British Columbia; Study Director: Mark Nigro, MD, University of British Columbia

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 24, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: urine; serum; Kidney stones; urinary stones; urinary stone disease
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: H06-00151