Stone Centre Urine and Serum Bank
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Purpose
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.
| Condition |
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Urinary Stone Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control |
| Official Title: | Stone Centre Urine and Serum Bank |
Urine and serum of stone-forming individuals and non-stone forming controls will be banked for analysis of protein biomarkers and predisposing factors. Ureteral stents removed from patients that would otherwise be discarded will be processed and stored to assess for bacterial and biofilm adherence.
Serum and Urine specimens will be collected and banked/retained. (The identity of of the patient will be forwarded to the Research Coordinator. All samples will be coded to preserve anonymity of the subjects. The code will be a combination of a group identifier (i.e whether the patient is a control or patient) as well as the date the sample was submitted and sample number. For example CTRL (control) 053108 (date submitted May 31, 2008) Sample 1. All distributed samples will be labeled using this code. Any requests for information will be referenced through this code. There will be no publication of results which identify the subjects' names.)
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | December 2012 |
| Groups/Cohorts |
|---|
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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." |
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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. |
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Accepts patients with stone disease and healthy volunteers as controls
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
Contacts and Locations| Contact: Olga Arsovska, BSc | (604) 875-4111 ext 62421 | olga.arsovska@ubc.ca |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Olga Arsovska, BSc 604 875-4111 ext 62421 olga.arsovska@ubc.ca | |
| UBC Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Olga Arsovska, BSc (604) 875-4111 ext 62421 olga.arsovska@ubc.ca | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00759343 History of Changes |
| Other Study ID Numbers: | H06-00151 |
| Study First Received: | September 23, 2008 |
| Last Updated: | July 6, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Kidney stones urinary stone disease urinary stones urine serum |
Additional relevant MeSH terms:
|
Calculi Urinary Calculi Pathological Conditions, Anatomical Urolithiasis Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013