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

Genomic Health

Status: Completed

Conditions: Non-muscle Invasive Bladder Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02969109

14-006

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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