A Randomized Trial of Surveillance of Low-Grade Non-Invasive Bladder Cancer Using Standard Follow-Up Versus Cystoscopy and NMP22 BladderChek Test

Study ID
STU 042011-120

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Contact
Allison Beaver
214-645-8788
allison.beaver@utsouthwestern.edu

Principal Investigator
Yair Lotan

Summary

The goal of this study is to validate these conclusions in a randomized trial comparing surveillance using cystoscopy and the NMP22(TM) BladderChek(TM) test (BladderChek) with cystoscopy and cytology (standard surveillance). Due to the higher level of concern of missed recurrence and progression in high grade lesions, we are confining the study to low grade, non-invasive tumors which represent more than 40% of all bladder tumors and have a very low risk of progression ( and amp;lt;5% at 5 years).

Participant Eligibility

1. Subject is at least 18 years of age, but is not older than 90 years.

2. Subjects diagnosed with low-grade non-invasive bladder cancer who are undergoing post-bladder cancer diagnosis surveillance every three months up to 6 months.

3. No macroscopic residual disease after transurethral resection of bladder tumor (TURBT).

4 Subject agrees to complete all aspects of the study and is willing and able to
provide informed consent.
5. Subject has negative results on 3 month cystoscopy