Clinical trial NCT00759343: Stone Centre Urine and Serum Bank
Official title: Stone Centre Urine and Serum Bank
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Stones
Keywords: Kidney stones
urinary stone disease
urinary stones
urine
serum
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Accepts patients with stone disease and healthy volunteers as controls

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: genetic factors in stone disease
timeFrame: one time sample
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben H. Chew, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Ryan Paterson, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Howard Fenster, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Caitlin Dobie
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Dirk Lange, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Mark Nigro, MD
role: STUDY_DIRECTOR
References: