Recruiting

Cxbladder

Sponsor:

London Health Sciences Centre

Code:

NCT03673202

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cx bladder Monitor test

Study Details

Brief 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).

Conditions

Bladder Cancer

Study ID

NCT03673202

Start date

Nov 26, 2018

Status verified date

Aug, 2019

Completion date

Nov, 2020

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by the clinical practitioner
2. Patients on an "all-comers" basis
3. Positive diagnosis for primary or recurrent bladder tumour within the past 5 years
4. Able provide a voided urine sample of the required minimum volume
5. Able to give written consent
6. Able and willing to comply with study requirements
7. Aged 18 years or older

Exclusion Criteria:

1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
2. Patients who had exposure to intravesical BCG, had completed induction BCG but without a subsequent clear cystoscopy
3. Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders,
4. Recent history of pyelonephritis
5. Total cystectomy of the bladder, neo bladders and illeal conduits
6. Previous muscle invasive bladder tumour (pT2 or greater)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cx bladder Monitor 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).

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 ]

Central Contacts and Locations

Central contacts

Shiva M Nair, MD, PhD

5196858500shiva.nair@lhsc.on.ca

Kaydee Connors, BSc

5196858500kaydee.connors@lhsc.on.ca

Locations

Victoria Hospital

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Kaydee Connors, BSc

519-685-8500Kaydee.Connors@lhsc.on.ca

Shiva M Nair, MD

519-685-8500shiva.nair@lhsc.on.ca

Principal Investigator:

Jonathan Izawa, MD

More Information

Sponsor

London Health Sciences Centre

Last update posted

Aug 14, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre on 2019-08-14.