Calculi Clinical Trial - Proteomic Study of Urinary Stone Disease

Status Completed

Clinical Trial Summary

Urinary protein levels are not routinely measured in stone patients while there is strong evidence that proteins play a role in the etiology of stones. The purpose of this study is to examine the urinary and serum proteins of stone formers compared to healthy subjects utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI). We hypothesize that there is a unique set of proteins expressed in serum and urine in stone patients that can be detected by SELDI. Ultimately, this will better our understanding of stone disease and help develop new prevention strategies.

Clinical Trial Description

Urinary stone disease affects 10% of the Canadian population during their lifetime and approximately half of these patients will have another episode within ten years. Currently, patients undergo metabolic testing (serum and 24 hour urine tests) to identify modifiable risk factors; however, no modifiable risk factors are identified in many patients, yet they continue to form stones. New techniques must be developed to identify stone patients at risk for future recurrences and ultimately to develop more specific prevention strategies.

Urinary protein levels are not routinely measured in stone patients while there is strong evidence that proteins play a role in the etiology of stones. The purpose of this study is to examine the urinary and serum proteins of stone formers compared to healthy subjects utilizing the high throughput method, Surface Enhanced Laser Desorption/Ionization (SELDI). We hypothesize that there is a unique set of proteins expressed in serum and urine in stone patients that can be detected by SELDI. Once a protein is identified as a biomarker, a specific assay similar to a quick and affordable dipstick test may be developed to identify those stone patients at risk of future stones. Ultimately, this will better our understanding of stone disease and help develop new prevention strategies.

Comparisons: protein profiles (serum/urine) of stone patients both during the presence of a stone and 6 weeks after they have passed it. comparison of stone profiles of stone patients with controls (non-forming stone patients). ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00199459
Study type	Observational
Source	Lawson Health Research Institute
Contact
Status	Completed
Phase	N/A
Start date	January 2005
Completion date	November 2008

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.