Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Nucleix

Status: Completed

Conditions: Bladder Cancer

Treatments: Other: Bladder EpiCheck

Study type: Interventional

Funder types: Industry

Identifiers

NCT02647112

UC-EpiCheck-EU-01

Details and patient eligibility

About

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Full description

Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Enrollment: 1,050 patients

Sex: All

Ages: 22 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
• Has all urothelial cell carcinoma tumor resected within the past 12 months
• Has a plan for cystoscopic surveillance

Exclusion criteria

• Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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1,050 participants in 2 patient groups

Bladder EpiCheck

Experimental group

Description:

Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology

Treatment:

Other: Bladder EpiCheck

Practice of medicine

No Intervention group

Description:

Practice of medicine including cystoscopy and cytology