Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00759343 |
| Other study ID # |
H06-00151 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2008 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
May 2022 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
Background:
While great strides have been made in the surgical treatment of kidney stones, the means to
identify high-risk patients for the prevention of kidney stones has lagged far behind.
Urinary stone disease is a common problem, causes significant disability and sometimes death,
and costs society 1.8 billion dollars each year. Therefore, it is important to identify those
patients who are at risk or in the process of developing kidney stones and develop procedures
which halt and/or prevent stone formation. Unfortunately, the current methods used for
identifying such patients are inadequate. Kidney stone patients undergo urine and serum
testing to attempt to identify substances that are either in excess or deficit in the body.
The levels of these substances are then adjusted with diet modification and/or the use of
medication. Often, patients who have corrected their abnormal values via diet or medications
or others who have no identifiable risk factors continue to form stones. Clearly, current
testing methods used to identify the continuous formation of stones are not enough, largely
due to the fact that the causes of this disease are not completely understood.
There exists strong evidence supporting a role for proteins, both in promoting stone
formation and in their prevention. Furthermore there may be hereditary factors (i.e. a family
history) that may increase the risk of some patients becoming chronic kidney stone formers.
This suggests a very complex cause of the disease and emphasizes the need and importance of
identifying the genes and proteins involved in formation of stones.
Research Methods:
Urine and serum samples will be collected from study and control groups. Study group will be
formed from confirmed kidney stone patients followed until post recovery, and the control
group from healthy individuals. Control patients will have no history of kidney stone
disease. Control subjects may be asked to undergo a screening renal ultrasound to ensure they
are stone free.
If there is ureteral stent placed after surgery in stone patients, once it is removed, it is
typically thrown into the garbage. With this study, it will be removed and the surface of the
stent will be examined for crystals and adherent proteins. The collected samples will be
submitted for SELDI analysis and to measure non-protein components. Each patient's serum
sample will also be submitted for protein analysis. Other samples will be stored indefinitely
until used. The urine, serum, and ureteral stents obtained in this study will be banked at
-80C in a locked, secure area.
Recruitment:
Recruitment of study group will be through the Urology and Stone Clinic in the Diamond Health
Care Centre at Vancouver General Hospital and Dr Joel Teichman's Practice at St Paul's
Hospitals. Patients will be asked to participate by a urologist (Drs Chew, Teichman, Nigro,
Fenster or Paterson) or the research coordinator. Control patients will be matched for age
and sex to the study group. They will have no history of stone disease. The consent form will
be provided to the participants by one of the investigators or a clinical research
coordinator involved in the study. This will occur in one of the urology clinics.
Risks:
The risks involved are minimal; drawing blood can result in possible bleeding, fainting,
bruising and infection. Urine collection has minimal risks.
Benefits:
There will not be any direct benefit from taking part in this urine and serum banking. We
anticipate that the information gained will benefit others in the future and provide
detection and treatment of urinary stone disease. No reimbursements or payments are being
offered, as there will be no expenses to the patients as a result of the banking of urine and
serum.
Confidentiality:
All samples will be coded to preserve anonymity of the subjects. Once distributed, the
samples will be labeled only with the code. At no point in time will the patient identifiers
leave the Stone Centre Serum and Urine Bank.
