Evaluation of the UroVysion Test in Predicting Recurrence and/or Progression of Disease in Patients Receiving initial BCG for Primary High Grade Papillary Ta-T1 and CIS Urothelial Carcinoma of the Bladder

Study ID
STU 062013-045

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services

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

Principal Investigator
Yair Lotan

Summary

This will be a multi-center, prospective, longitudinal study to determine the use of uroVysion to predict bladder cancer recurrence as defined by histologically proven tumor after bladder biopsies or TuRBT or progression of disease, as defined by the development of muscle invasive disease, in patients with primary high grade papillary(Ta-T1) or CiS urothelial carcinoma bladder tumors and going to receive initial BCG therapy or BCG plus interferon.

Participant Eligibility

Only patients who meet all of the following criteria will be included:
a. Patient has biopsy proven primary or recurrent high grade papillary or CIS urothelial carcinoma of the bladder and pathology results are available;
b. Undergoing at least one cycle of initial BCG therapy or BCG plus interferon which consists of six weekly instillations as treatment for bladder cancer;
c. 18 years of age or older;
d. Patient is able to undergo standard of practice monitoring including cystoscopy and biopsy;
e. Signed informed consent form (Appendix A) prior to participating in the study