Stone Centre Urine and Serum Bank
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00759343|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2008
Last Update Posted : March 16, 2016
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.
The objective of this research is to identify protein species or other compounds responsible for or contributing to kidney stone initiation and propagation.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Observational Model:||Case Control|
|Official Title:||Stone Centre Urine and Serum Bank|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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."
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.
- genetic factors in stone disease [ Time Frame: one time sample ]
Biospecimen Retention: Samples With DNA
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, de-identified, and banked/retained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759343
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Vancouver, British Columbia, Canada|
|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|