A Novel Multiplex Elisa Assay for Surveilling Patients with a History of Bladder Cancer

Study ID
STU 092016-079

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services

Contact
Allison Beaver
214/645-8788
ALLISON.BEAVER@UTSouthwestern.edu

Principal Investigator
Yair Lotan, M.D.

Summary

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.

Participant Eligibility

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)