Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer

Completed

Conditions studied: Non-muscle Invasive Bladder Cancer

In brief

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.

Key facts

Study ID

NCT02969109

Run by

Genomic Health®, Inc.

People needed

417

Starts

2015-10-01

Expected to finish

2018-09-18

Last updated by the study team

2021-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Institute for Prostate and Urologic Cancers - University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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