Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Bladder EpiCheck

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

Group Type EXPERIMENTAL

Bladder EpiCheck

Intervention Type OTHER

Urine test for the monitoring of bladder cancer recurrence

Practice of medicine

Practice of medicine including cystoscopy and cytology

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bladder EpiCheck

Urine test for the monitoring of bladder cancer recurrence

Intervention Type OTHER

Eligibility Criteria

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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