Clinical Validation of a Urine-based Assay With Genomic and Epigenomic Markers for Predicting Recurrence During Surveillance for Non-muscle Invasive Bladder Cancer

Genomic Health®, Inc.1 site in 1 country417 target enrollmentOctober 2015

ConditionsNon-muscle Invasive Bladder Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-muscle Invasive Bladder Cancer
Sponsor: Genomic Health®, Inc.
Enrollment: 417
Locations: 1
Primary Endpoint: The recurrence status based on the pathology results
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A study to validate, in a prospective manner, the ability of the predefined Genomic Health bladder cancer assay to detect recurrence in patients undergoing surveillance for non-muscle invasive bladder cancer.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

September 18, 2018

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Genomic Health®, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with a prior diagnosis of non-muscle invasive, ≤T1, urothelial cell carcinoma of the bladder scheduled to undergo surveillance cystoscopy.

Exclusion Criteria

•Patients younger than 18 years
•Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell carcinoma of the bladder
•Patients who have had a cystectomy or prior diagnosis of muscle invasive disease (T2 or greater)
•Patients who are unable or unwilling to give informed consent