Stone Centre Urine and Serum Bank

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00759343
First received: September 23, 2008
Last updated: February 24, 2015
Last verified: February 2015
  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
Kidney Stones

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Stone Centre Urine and Serum Bank

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • genetic factors in stone disease [ Time Frame: one time sample ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 500
Study Start Date: June 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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."

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
Study Population

Accepts patients with stone disease and healthy volunteers as controls

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759343

Locations
Canada, British Columbia
UBC Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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: February 24, 2015
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Kidney stones
urinary stone disease
urinary stones
urine
serum

ClinicalTrials.gov processed this record on March 31, 2015