AzTrials
AzTrials

Kidney StonesNCT00759343

Stone Centre Urine and Serum Bank

An observational study of Kidney Stones, run by University of British Columbia at 2 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Kidney Stones
How many people
500 participants
Where
2 sitesCanada
Study dates
Jun 2008to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Accepts patients with stone disease and healthy volunteers as controls

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy,
  • Positive Urine Culture,
  • Active cancer,
  • Recurrent urinary infections,
  • Gross hematuria,
  • Inability to provide informed consent,
Show all 10Show fewer
  • Investigator's refusal to include,
  • CONTROLS ONLY:
  • Family history of stones,
  • History of stones

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • UBC Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

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.

Read the detailed 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.

Conditions
Kidney Stones
Keywords
Kidney stones, urinary stone disease, urinary stones, urine, serum
Medical subject headings
Kidney Calculi, Urinary Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00759343
Study groupRoleWhat they receive
Control GroupThe 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 GroupThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. genetic factors in stone disease

    We are to determine the genetic factors that contributes to kidney stone disease from the microbiome analysis of urine and serum samples.

    Measured: one time sample

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00759343
Sponsor's protocol ID
H06-00151
Status last verified
May 2022
First submitted
23 Sep 2008
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Stones, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

genetic factors in stone disease (time frame: one time sample). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in