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NCT02969109 Clinical Trial

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

Non-muscle Invasive Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02969109
Other study ID # 14-006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date September 18, 2018

Study information
Verified date February 2021
Source Genomic Health®, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 417
Est. completion date September 18, 2018
Est. primary completion date September 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Institute for Prostate and Urologic Cancers - University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Genomic Health®, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The recurrence status based on the pathology results 1 year
Primary The Genomic Health bladder cancer assay results. 1 year
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