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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted25 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben H. Chew, MD, FRCSC, Principal investigator, University of British ColumbiaRyan Paterson, MD, Study director, University of British ColumbiaHoward Fenster, MD, Study director, University of British ColumbiaCaitlin Dobie, Study director, University of British ColumbiaDirk Lange, MD, Study director, University of British ColumbiaMark Nigro, MD, Study director, University of British Columbia
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stone Centre Urine and Serum Bank
- ClinicalTrials.gov ID
- NCT00759343
- Acronym / sponsor ID
- H06-00151
- Conditions
- Kidney Stones
- Keywords
- Kidney stones, urinary stone disease, urinary stones, urine, serum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Accepts patients with stone disease and healthy volunteers as controls
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- Pregnancy,
- Positive Urine Culture,
- Active cancer,
- Recurrent urinary infections,
- Gross hematuria,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genetic factors in stone disease
Time frame: one time sample
We are to determine the genetic factors that contributes to kidney stone disease from the microbiome analysis of urine and serum samples.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Related InfoLink provided by the sponsor.
Related trials for Kidney Stones
Not yet recruiting
Automated Versus Manual Irrigation During Flexible Ureteroscopy
Renal Stone Disease
Not yet recruiting
Optimal Intrarenal Pressure During Flexible Ureteroscopy
Renal Stone Disease
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben H. Chew, MD, FRCSC principal investigator
University of British Columbia
Ryan Paterson, MD study director
University of British Columbia
Howard Fenster, MD study director
University of British Columbia
2 sites in 1 country: see every site and its status.
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.