Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder
Completed
Conditions studied: Bladder Cancer, Biomarkers
In brief
To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patients with a positive diagnosis for bladder cancer by current standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these markers will be assessed, as well as the degree of non-specific signal attributable to other sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally, post-operative urine will be assessed for the presence of these markers. To the extent this biomarker panel can be determined to be specific and sensitive, it may serve as an indicator of the degree to which the surgical intervention successfully eradicated the underlying disease. The investigators also aim to assess the stability of a biomarker signature in urine but evaluating several patient specimens over various time points throughout the day.
Key facts
- Study ID
- NCT02745301
- Run by
- Vanderbilt University
- People needed
- 50
- Starts
- 2016-04-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2018-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Suspected or confirmed urothelial type bladder cancer
- Scheduled for a transurethral resection of bladder tumor (TURBT) or cystectomy
You may not qualify if…
- Less than 18 years of age
- Known concurrent upper urinary tract disease
- History of bladder or prostate radiation
- Patients who are unwilling or unable to give consent
Where it is running
- The Vanderbilt Clinic, VUMC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.