A Novel Multiplex Elisa Assay for Surveilling Patients with a History of Bladder Cancer
- Clements University Hospital
- UT Southwestern Ambulatory Services
Yair Lotan, M.D.
This is a phase 3 single arm study comparing the diagnostic capabilities of multiplex eLiSa assay to VuC and nMP22 BladderChek to reference standard of cystoscopy in participants with a history of bladder cancer on tumor surveillance.
Participants must be:
* Age 18 years or older
* Have a history of non-muscle invasive bladder cancer or muscle invasive bladder cancer treated by bladder sparing techniques (or not yet treated) and diagnosed within the past 24 months on cystoscopic surveillance
* Participants may be treated with adjuvant intravesical therapy
* Willing and able to give written informed consent (see Appendix 1)
* Be willing to adhere to the surveillance regimen (high risk and intermediate risk seen every 3 months for 2 years; low risk seen every 6-12 months for 2 years)