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

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Zale Lipshy University Hospital
  • Parkland Health & Hospital System

Allison Beaver

Principal Investigator
Yair Lotan, M.D.


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]) and FiSH( fluroescence in situ hybridization) 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.All eligible patients presenting with a recent history of primary gross (macroscopic) hematuria and who are undergoing cystoscopy (either flexible or rigid) for the investigation of possible urological cancer will be invited to participate
5. Able and willing to comply with study requirements
6. Patient is 18 years of age or older