A Clinical, non-intervention study of the Cxbladder(RegisteredTM) urine test for the detection of recurrent urinary tract Urothelial Carcinoma (UC)

Study ID
STU 112012-018

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

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

Principal Investigator
Yair Lotan

Summary

This study aims to evaluate the performance of the Cxbladder[RegisteredTM] test, to compare Cxbladder[RegisteredTM] with urine cytology and the nMP22[RegisteredTM] tests (eLiSa and BladderChek[RegisteredTM]) using cystoscopy plus follow up as a gold standard in the investigation of patients with a history of urinary tract uC who are undergoing monitoring for recurrence of the disease. This study is selecting eligible patients from the united States population.

Participant Eligibility

1. Positive diagnosis for primary or recurrent urinary tract UC over the past 2 years
2. Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by clinical practitioner
3. Able to provide a voided urine sample of the required minimum volume
4. Able to give written informed consent
5. Able and willing to comply with study requirements
6. Patient is 18 years of age or older