Bladder CancerNCT03673202
The Cxbladder Rule-out of Recurrent Urothelial Carcinoma
An observational study of Bladder Cancer, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
This observational study is designed to collect urine and relevant clinical information from patients who have a known diagnosis of bladder cancer and currently on clinically driven surveillance. The study aims to compare the urine test to the flexible cystoscopy procedure (which the patient is already scheduled). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Cx bladder Monitor test
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 26 Nov 2018to Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing flexible cystoscopy on a clinically determined surveillance schedule who have been previous diagnosed with bladder cancer are eligible. These patients are recruited prior to their investigation, and a urine sample collected. The patients clinical events are then followed (observed) for 12 months following the urine sample collection.
Who may be able to join
- Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by the clinical practitioner
- Patients on an "all-comers" basis
- Positive diagnosis for primary or recurrent bladder tumour within the past 5 years
- Able provide a voided urine sample of the required minimum volume
- Able to give written consent
- Able and willing to comply with study requirements
- Aged 18 years or older
Who cannot join
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
- Patients who had exposure to intravesical BCG, had completed induction BCG but without a subsequent clear cystoscopy
- Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders,
- Recent history of pyelonephritis
- Total cystectomy of the bladder, neo bladders and illeal conduits
- Previous muscle invasive bladder tumour (pT2 or greater)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital
London, Ontario, N6A 5W9
Kaydee Connors, BSc, 519-685-8500 ext. 56366, Kaydee.Connors@lhsc.on.ca
Shiva M Nair, MD, 519-685-8500 ext. 13933, shiva.nair@lhsc.on.ca
About this study
Official title: A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urinary Tract Urothelial Carcinoma
This observational study is designed to collect urine and relevant clinical information from patients who have a known diagnosis of bladder cancer and currently on clinically driven surveillance. The study aims to compare the urine test to the flexible cystoscopy procedure (which the patient is already scheduled).
Read the detailed description
There are approximately 360,000 new cases of bladder cancer diagnosed globally each year. In addition, this disease is responsible for 145,000 deaths annually (Parkin et al 2005). Treatments for this cancer range from transurethral resection of the bladder tumor (TURBT) for low stage, non-invasive tumors, to the more drastic option of radical cystectomy with pelvic lymph node dissection for those tumors that are found to have invaded into the muscularis propria (Parekh et al 2006). Currently, the standard of care for diagnosing bladder cancer involves a combination of flexible cystoscopy and urine cytology, which is usually performed after the patient presents with episodes of gross hematuria. Following these evaluations, if evidence exists that warrants further investigation for bladder cancer a TURBT is performed and accurate staging and grading of the tumor can occur (O'Sullivan et al 2012). For those patients who have localized disease and have bladder preservation therapies, long term surveillance (in high grade disease this is life-long) is required to monitor for recurrence of tumor (Sylvester et al 2006). While cystoscopy has proven to be an accurate tool (sensitivity 80%) in the surveillance of bladder cancer, it is nonetheless a highly invasive procedure (Jocham et al 2008). In addition, urine cytology, which has served as the traditional adjunct to cystoscopy operates with a modest degree of sensitivity and therefore potential to deliver false negatives where malignant cells are not seen and false positives for bladder cancer in patients with an acute or chronically inflamed urothlelium (Grossman et al 2005). This leaves room for the development of a diagnostic test that is able to deliver results with the specificity of cystoscopy but without the potential for false negatives seen with urine cytology.
Recently, studies have shown that certain genetic markers exist that accompany the occurrence of bladder cancer and can accurately discriminate between bladder tumors and normal tissue. These genetic markers also show promise in being able to deliver additional information regarding the disease state of this cancer, such the stage and grade of the tumor (Dyrskjot et al 2003; Dyrskjot et al 2005; Thykjaer et al 2001). The informative nature of these mRNA expression profiles, along with the frequency with which tumor exfoliation into the urine occurs, has led to the development of a urine-based test that has the potential to diagnose and stratify bladder cancer. This urine test, known as Cxbladder Monitor, was developed by Pacific Edge Limited and is able to perform a combinatory analysis of the expression profiles of five genetic biomarkers (IGF, HOXA, MDK, CDC and IL8R gene expression) and two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected). This test has the potential, with further testing, to produce a consolidated diagnostic score that is able to accurately risk stratify a given patient for recurrence of bladder cancer based on tumor characteristics. The five genetic markers include CDC2 (a gene involved in cell cycle activity and DNA synthesis) (O'Sullivan et al 2012), HOXA13 (transcription factor involved in morphogenesis and differentiation of the genitourinary tract) (Scott et al 2005), IGFBP5 (affects processes such as such as development, differentiation, and cellular survival) (Beattie et al 2006), MDK (a heparin binding growth factor expressed during embryogenesis) (Kadomatsu et al 2004), and CXCR2 which is expressed in neutrophils and is increased in non-malignant, inflammatory conditions. This marker is essential as it is helpful in reducing the risk of false positive results in patients with an inflamed urothelium (O'Sullivan et al 2012). The Cxbladder test is able to take into account the expression of all these relevant genetic markers and analyze their expression profiles and interactions via a 2 way linear discriminate algorithm to form a score that is able to predict the recurrence of bladder cancer. The success of these preliminary studies with Cxbladder show that it has a strong potential to be used as a alternate to urine cytology and challenge cytology's routine accompaniment to cystoscopy. More importantly, the use of Cxbladder in the surveillance patient has the potential to decrease the frequency with which cystoscopy would need to be performed, adjudicate equivocal cystoscopy and cytology atypia.
- Conditions
- Bladder Cancer
- Being tested
- Cx bladder Monitor test
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cx bladder Monitor testDiagnostic test
Cxbladder Monitor is a non-invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma and also two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected).
| Study group | Role | What they receive |
|---|---|---|
| UC monitoring patients | Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations. All patients will have urine samples taken and analyzed for urine cytology and Cxbladder. No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes. Receives: Diagnostic Test: Cx bladder Monitor test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
To validate the Performance Characteristics (sensitivity, area under the ROC curve, positive and negative predictive values and test negative rate) of the Cxbladder for the detection of recurrent UC in the absence of inflammation in patients with a recent history of urinary tract UC who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard for determination of clinical truth is cystoscopy confirmed by pathology, plus any follow up investigations relating to the current visit.
Measured: 24 months
Secondary outcomes (5)
Detection rates of Cx bladder test
To define and the validate the Performance Characteristics of the Cxbladder for the detection of recurrent UC in local population patients with a recent history of urinary tract UC who have been treated according to standard practice and are undergoing routine investigative cystoscopy
Measured: 24 months
Comparison of Cxbladder theoretical capacity to reduce use of flexible cystoscopy for the monitoring for recurrence of urothelial carcinoma
To estimate the theoretical clinical outcome of patients under the Standard Of Care tested with Cxbladder before investigative cystoscopy to determine the true proportion requiring cystoscopy and follow up and thereby determining the potential of Cxbladder for reducing the cystoscopy burden on patients undergoing monitoring for recurrence
Measured: 24 months
Comparison of the Cxbladder test and cytology test performance on the same sample
Performance characteristics (sensitivity, specificity, rule-out rate, PPV and NPV) of the Cxbladder and urine cytology on the same voided urine sample.
Measured: 12 months
Performance of Cxbladder test in atypical findings of cytology and cystoscopy
To compare and contrast atypical cytology and / or equivocal cystoscopy with the performance characteristics of Cxbladder signatures
Measured: 24 months
Examine urinary microbiome profile in patients with urothelial cancer
Compare differences in microbiome profiles in patients with urothelial cancer and those without
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start26 Nov 2018
- Primary completionAug 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Edge Limited
- Responsible party
- Principal investigator, Dr. Jonathan Izawa, London Health Sciences Centre
- Investigators
- Jonathan Izawa, MD, Principal investigator, Schulich School of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673202
- Sponsor's protocol ID
- Waiting
- Status last verified
- Aug 2019
- First submitted
- 6 Sep 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
PubMed 15761078Parekh DJ, Bochner BH, Dalbagni G. Superficial and muscle-invasive bladder cancer: principles of management for outcomes assessments. J Clin Oncol. 2006 Dec 10;24(35):5519-27. doi: 10.1200/JCO.2006.08.5431.
PubMed 17158537O'Sullivan P, Sharples K, Dalphin M, Davidson P, Gilling P, Cambridge L, Harvey J, Toro T, Giles N, Luxmanan C, Alves CF, Yoon HS, Hinder V, Masters J, Kennedy-Smith A, Beaven T, Guilford PJ. A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria. J Urol. 2012 Sep;188(3):741-7. doi: 10.1016/j.juro.2012.05.003. Epub 2012 Jul 19.
PubMed 22818138Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
PubMed 16442208Jocham D, Stepp H, Waidelich R. Photodynamic diagnosis in urology: state-of-the-art. Eur Urol. 2008 Jun;53(6):1138-48. doi: 10.1016/j.eururo.2007.11.048. Epub 2007 Dec 10.
PubMed 18096307Grossman HB, Messing E, Soloway M, Tomera K, Katz G, Berger Y, Shen Y. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005 Feb 16;293(7):810-6. doi: 10.1001/jama.293.7.810.
PubMed 15713770Dyrskjot L, Thykjaer T, Kruhoffer M, Jensen JL, Marcussen N, Hamilton-Dutoit S, Wolf H, Orntoft TF. Identifying distinct classes of bladder carcinoma using microarrays. Nat Genet. 2003 Jan;33(1):90-6. doi: 10.1038/ng1061. Epub 2002 Dec 9.
PubMed 12469123Dyrskjot L, Zieger K, Kruhoffer M, Thykjaer T, Jensen JL, Primdahl H, Aziz N, Marcussen N, Moller K, Orntoft TF. A molecular signature in superficial bladder carcinoma predicts clinical outcome. Clin Cancer Res. 2005 Jun 1;11(11):4029-36. doi: 10.1158/1078-0432.CCR-04-2095.
PubMed 15930337Thykjaer T, Workman C, Kruhoffer M, Demtroder K, Wolf H, Andersen LD, Frederiksen CM, Knudsen S, Orntoft TF. Identification of gene expression patterns in superficial and invasive human bladder cancer. Cancer Res. 2001 Mar 15;61(6):2492-9.
PubMed 11289120Scott V, Morgan EA, Stadler HS. Genitourinary functions of Hoxa13 and Hoxd13. J Biochem. 2005 Jun;137(6):671-6. doi: 10.1093/jb/mvi086.
PubMed 16002988Beattie J, Allan GJ, Lochrie JD, Flint DJ. Insulin-like growth factor-binding protein-5 (IGFBP-5): a critical member of the IGF axis. Biochem J. 2006 Apr 1;395(1):1-19. doi: 10.1042/BJ20060086.
PubMed 16526944Kadomatsu K, Muramatsu T. Midkine and pleiotrophin in neural development and cancer. Cancer Lett. 2004 Feb 20;204(2):127-43. doi: 10.1016/S0304-3835(03)00450-6.
PubMed 15013213
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urinary Tract Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03673202
- Acronym / sponsor ID
- Waiting
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Pacific Edge Limited
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 17 Sep 2018 (actual)
- 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.
This observational study is designed to collect urine and relevant clinical information from patients who have a known diagnosis of bladder cancer and currently on clinically driven surveillance. The study aims to compare the urine test to the flexible cystoscopy procedure (which the patient is already scheduled).
Detailed description
There are approximately 360,000 new cases of bladder cancer diagnosed globally each year. In addition, this disease is responsible for 145,000 deaths annually (Parkin et al 2005). Treatments for this cancer range from transurethral resection of the bladder tumor (TURBT) for low stage, non-invasive tumors, to the more drastic option of radical cystectomy with pelvic lymph node dissection for those tumors that are found to have invaded into the muscularis propria (Parekh et al 2006). Currently, the standard of care for diagnosing bladder cancer involves a combination of flexible cystoscopy and urine cytology, which is usually performed after the patient presents with episodes of gross hematuria. Following these evaluations, if evidence exists that warrants further investigation for bladder cancer a TURBT is performed and accurate staging and grading of the tumor can occur (O'Sullivan et al 2012). For those patients who have localized disease and have bladder preservation therapies, long term surveillance (in high grade disease this is life-long) is required to monitor for recurrence of tumor (Sylvester et al 2006). While cystoscopy has proven to be an accurate tool (sensitivity 80%) in the surveillance of bladder cancer, it is nonetheless a highly invasive procedure (Jocham et al 2008). In addition, urine cytology, which has served as the traditional adjunct to cystoscopy operates with a modest degree of sensitivity and therefore potential to deliver false negatives where malignant cells are not seen and false positives for bladder cancer in patients with an acute or chronically inflamed urothlelium (Grossman et al 2005). This leaves room for the development of a diagnostic test that is able to deliver results with the specificity of cystoscopy but without the potential for false negatives seen with urine cytology.
Recently, studies have shown that certain genetic markers exist that accompany the occurrence of bladder cancer and can accurately discriminate between bladder tumors and normal tissue. These genetic markers also show promise in being able to deliver additional information regarding the disease state of this cancer, such the stage and grade of the tumor (Dyrskjot et al 2003; Dyrskjot et al 2005; Thykjaer et al 2001). The informative nature of these mRNA expression profiles, along with the frequency with which tumor exfoliation into the urine occurs, has led to the development of a urine-based test that has the potential to diagnose and stratify bladder cancer. This urine test, known as Cxbladder Monitor, was developed by Pacific Edge Limited and is able to perform a combinatory analysis of the expression profiles of five genetic biomarkers (IGF, HOXA, MDK, CDC and IL8R gene expression) and two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected). This test has the potential, with further testing, to produce a consolidated diagnostic score that is able to accurately risk stratify a given patient for recurrence of bladder cancer based on tumor characteristics. The five genetic markers include CDC2 (a gene involved in cell cycle activity and DNA synthesis) (O'Sullivan et al 2012), HOXA13 (transcription factor involved in morphogenesis and differentiation of the genitourinary tract) (Scott et al 2005), IGFBP5 (affects processes such as such as development, differentiation, and cellular survival) (Beattie et al 2006), MDK (a heparin binding growth factor expressed during embryogenesis) (Kadomatsu et al 2004), and CXCR2 which is expressed in neutrophils and is increased in non-malignant, inflammatory conditions. This marker is essential as it is helpful in reducing the risk of false positive results in patients with an inflamed urothelium (O'Sullivan et al 2012). The Cxbladder test is able to take into account the expression of all these relevant genetic markers and analyze their expression profiles and interactions via a 2 way linear discriminate algorithm to form a score that is able to predict the recurrence of bladder cancer. The success of these preliminary studies with Cxbladder show that it has a strong potential to be used as a alternate to urine cytology and challenge cytology's routine accompaniment to cystoscopy. More importantly, the use of Cxbladder in the surveillance patient has the potential to decrease the frequency with which cystoscopy would need to be performed, adjudicate equivocal cystoscopy and cytology atypia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC monitoring patients | – | Diagnostic Test: Cx bladder Monitor testPatients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations. All patients will have urine samples taken and analyzed for urine cytology and Cxbladder. No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing flexible cystoscopy on a clinically determined surveillance schedule who have been previous diagnosed with bladder cancer are eligible. These patients are recruited prior to their investigation, and a urine sample collected. The patients clinical events are then followed (observed) for 12 months following the urine sample collection.
Key inclusion criteria (7 listed)
- Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by the clinical practitioner
- Patients on an "all-comers" basis
- Positive diagnosis for primary or recurrent bladder tumour within the past 5 years
- Able provide a voided urine sample of the required minimum volume
- Able to give written consent
Key exclusion criteria (6 listed)
- Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
- Patients who had exposure to intravesical BCG, had completed induction BCG but without a subsequent clear cystoscopy
- Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders,
- Recent history of pyelonephritis
- Total cystectomy of the bladder, neo bladders and illeal conduits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cx bladder Monitor testCxbladder Monitor is a non-invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma and also two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected). | Diagnostic test | UC monitoring patients |
Primary outcome
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.
Time frame: 24 months
To validate the Performance Characteristics (sensitivity, area under the ROC curve, positive and negative predictive values and test negative rate) of the Cxbladder for the detection of recurrent UC in the absence of inflammation in patients with a recent history of urinary tract UC who have been treated according to standard practice and are undergoing routine investigative cystoscopy. The gold standard for determination of clinical truth is cystoscopy confirmed by pathology, plus any follow up investigations relating to the current visit.
5 secondary outcomes
Detection rates of Cx bladder test
Time frame: 24 months
Comparison of Cxbladder theoretical capacity to reduce use of flexible cystoscopy for the monitoring for recurrence of urothelial carcinoma
Time frame: 24 months
Comparison of the Cxbladder test and cytology test performance on the same sample
Time frame: 12 months
Performance of Cxbladder test in atypical findings of cytology and cystoscopy
Time frame: 24 months
Examine urinary microbiome profile in patients with urothelial cancer
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Background: PubMed 15761078Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.
- Background: PubMed 17158537Parekh DJ, Bochner BH, Dalbagni G. Superficial and muscle-invasive bladder cancer: principles of management for outcomes assessments. J Clin Oncol. 2006 Dec 10;24(35):5519-27. doi: 10.1200/JCO.2006.08.5431.
- Background: PubMed 22818138O'Sullivan P, Sharples K, Dalphin M, Davidson P, Gilling P, Cambridge L, Harvey J, Toro T, Giles N, Luxmanan C, Alves CF, Yoon HS, Hinder V, Masters J, Kennedy-Smith A, Beaven T, Guilford PJ. A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria. J Urol. 2012 Sep;188(3):741-7. doi: 10.1016/j.juro.2012.05.003. Epub 2012 Jul 19.
- Background: PubMed 16442208Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
- Background: PubMed 18096307Jocham D, Stepp H, Waidelich R. Photodynamic diagnosis in urology: state-of-the-art. Eur Urol. 2008 Jun;53(6):1138-48. doi: 10.1016/j.eururo.2007.11.048. Epub 2007 Dec 10.
- Background: PubMed 15713770Grossman HB, Messing E, Soloway M, Tomera K, Katz G, Berger Y, Shen Y. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005 Feb 16;293(7):810-6. doi: 10.1001/jama.293.7.810.
- Background: PubMed 12469123Dyrskjot L, Thykjaer T, Kruhoffer M, Jensen JL, Marcussen N, Hamilton-Dutoit S, Wolf H, Orntoft TF. Identifying distinct classes of bladder carcinoma using microarrays. Nat Genet. 2003 Jan;33(1):90-6. doi: 10.1038/ng1061. Epub 2002 Dec 9.
- Background: PubMed 15930337Dyrskjot L, Zieger K, Kruhoffer M, Thykjaer T, Jensen JL, Primdahl H, Aziz N, Marcussen N, Moller K, Orntoft TF. A molecular signature in superficial bladder carcinoma predicts clinical outcome. Clin Cancer Res. 2005 Jun 1;11(11):4029-36. doi: 10.1158/1078-0432.CCR-04-2095.
- Background: PubMed 11289120Thykjaer T, Workman C, Kruhoffer M, Demtroder K, Wolf H, Andersen LD, Frederiksen CM, Knudsen S, Orntoft TF. Identification of gene expression patterns in superficial and invasive human bladder cancer. Cancer Res. 2001 Mar 15;61(6):2492-9.
- Background: PubMed 16002988Scott V, Morgan EA, Stadler HS. Genitourinary functions of Hoxa13 and Hoxd13. J Biochem. 2005 Jun;137(6):671-6. doi: 10.1093/jb/mvi086.
- Background: PubMed 16526944Beattie J, Allan GJ, Lochrie JD, Flint DJ. Insulin-like growth factor-binding protein-5 (IGFBP-5): a critical member of the IGF axis. Biochem J. 2006 Apr 1;395(1):1-19. doi: 10.1042/BJ20060086.
- Background: PubMed 15013213Kadomatsu K, Muramatsu T. Midkine and pleiotrophin in neural development and cancer. Cancer Lett. 2004 Feb 20;204(2):127-43. doi: 10.1016/S0304-3835(03)00450-6.
- Individual participant dataSharing planned: No
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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.
Jonathan Izawa, MD principal investigator
Schulich School of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by London Health Sciences Centre at 1 site 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 7 inclusion and 6 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Shiva M Nair, MD, PhD (5196858500 ext. 13933, shiva.nair@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03673202, which also lists 12 linked publications.
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 14 Aug 2019.