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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02969109

Enrollment

417

Registered

2016-11-21

Start date

2015-10-31

Completion date

2018-09-18

Last updated

2021-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle Invasive Bladder Cancer

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The recurrence status based on the pathology results	1 year
The Genomic Health bladder cancer assay results.	1 year

Countries

United States

Outcome results