Status:
COMPLETED
Proteomic Study of Urinary Stone Disease
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
University of Western Ontario, Canada
Conditions:
Urinary Calculi
Hyperoxaluria
Eligibility:
All Genders
18-65 years
Brief 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 urin...
Detailed 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 meta...
Eligibility Criteria
Inclusion
- Controls:
- Ages 18 to 65 years of age
- No history of stone disease and no radiographical evidence of stone (as demonstrated by negative ultrasound)
- No family history of stones
- Healthy and no autoimmune or systemic disease that may affect renal function (see exclusion criteria)
- Stone patients
- Ages 18 to 65 years of age
- Solitary stone of any size, in any location along the urinary tract (except lower renal calyceal stones and bladder stones)
- Radiology of any modality proving the existence of the stone (ultrasound, computed tomography, intravenous pyelogram, kidney-ureter-bladder x-ray)
Exclusion
- ALL:
- Pregnant females
- Male patients treated for with benign prostate hyperplasia (BPH) (ongoing medical treatment or surgical intervention within 6 months)
- Positive urine culture
- Any cancer (excluding superficial skin, brain)
- Chronic Recurrent urinary infections (prostate, cystitis, vaginosis/vaginitis)
- Gross hematuria
- Autoimmune disease that may affect renal function (eg Systemic lupus erythematosus)
- Renal dysfunction or its common causes:
- Diabetes
- Uncontrolled hypertension (with concurrent microalbuminuria) (diastolic BP \> 90 mmHg)
- glomerulonephritis
- Renal transplant
- Genetic stone disease (e.g. Cystine stones, xanthinuria)
- Medullary sponge kidney, or other renal anomalies such as horseshoe kidney
- GI disorders: Inflammatory bowel disease, short bowel
- Hypercalcemic disorders (hyperparathyroidism, sarcoidosis, Paget's disease)
- Renal tubular acidosis
- Immunodeficient patients e.g. HIV (indinavir stones)
- Unable to provide informed consent
- Anyone in the opinion of the investigator who would be inappropriate
- Controls :
- In addition to criteria above.....
- persistent thiazide use
- Family history of stones (this will exclude any genetic factors since a positive family history increases the risk of urolithiasis)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00199459
Start Date
January 1 2005
End Date
November 1 2008
Last Update
September 3 2009
Active Locations (1)
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1
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2