Proteomic Study of Urinary Stone Disease

NCT00199459 | Completed

• 2 other identifiers: R-04-481PSI 04-041
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Urinary Calculi; Hyperoxaluria; Calculi

Keywords

calculi; proteomics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational study will compare stone formers meeting the inclusion criteria with a cohort of age and sex matched non-stone formers as controls.

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator
• University of Western Ontario, Canada: collaborator

Study Sites (1)

St. Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Urinary Calculi; Hyperoxaluria; Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Kidney Diseases

Study Officials

• John D Denstedt, MD, FRCSC

  The University of Western Ontario (Professor)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 3, 2009

Record last verified: 2009-09

Locations

CA (1)