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

NCT ID: NCT02969109

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

417 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Non-muscle Invasive Bladder Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genomic Health®, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Prostate and Urologic Cancers - University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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14-006

Identifier Type: -

Identifier Source: org_study_id

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