Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
NCT ID: NCT03125460
Last Updated: 2020-02-07
Study Results
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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COMPLETED
424 participants
OBSERVATIONAL
2016-12-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Initial Enrollment
Initial enrollment of patients with history of bladder cancer
Xpert Bladder Cancer Monitor
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
Longitudinal Cohort
Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient
Xpert Bladder Cancer Monitor
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
Interventions
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Xpert Bladder Cancer Monitor
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
Eligibility Criteria
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Inclusion Criteria
* Subject has provided documented informed consent as required by the reviewing IRB or EC. Experimental Bill of Rights will be documented for all subjects enrolled in applicable states.
* Subject is considered disease positive within 12 months (365 days) of enrollment.
* At the time of the enrollment visit, the subject is scheduled for a standard of care cystoscopy which will be completed within 3 days of providing a urine specimen.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at the enrollment visit.
* Subject has agreed to provide at least 60 mL of voided urine for study purposes at each subsequent standard of care cystoscopy visit for at least 12 months (365 days) following enrollment if the subject will enter the Longitudinal cohort.
* Any subject considered anticipatory positive at the initial visit shall be enrolled into the longitudinal cohort. For each anticipatory positive enrolled into the longitudinal cohort a random disease negative subject shall be enrolled.
Exclusion
* Subject has been previously enrolled into the study.
* Urine specimen to be used for study purposes is from the first morning void.
* Subject has had an excision procedure within six weeks (42 days) of enrollment.
* The subject is not scheduled for a standard of care cystoscopy visit within 12 months (365 days) following enrollment.
40 Years
100 Years
ALL
No
Sponsors
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Cepheid
INDUSTRY
Responsible Party
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Locations
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PAVA
Palo Alto, California, United States
The Urology Center of Colorado, P.C.
Denver, Colorado, United States
Urology Associates, P.C.
Englewood, Colorado, United States
North Idaho Urology
Coeur d'Alene, Idaho, United States
Idaho Urologic Institute
Meridian, Idaho, United States
UroPartners
Melrose Park, Illinois, United States
Five Valleys Urology
Missoula, Montana, United States
Weill Cornell Medicine
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
UT Southwestern
Dallas, Texas, United States
Virginia Urology
Richmond, Virginia, United States
The Male/Female Health and Research Centre
Barrie, Ontario, Canada
G Kenneth Jansz Medicine Professional Corp.
Burlington, Ontario, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada
Urology Clinic of Dr. Goldfarb
North Bay, Ontario, Canada
Urologic Clinic of Stanley Flax
North York, Ontario, Canada
Radboud University Medical Center
Nijmegen, , Netherlands
Countries
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Other Identifiers
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170
Identifier Type: -
Identifier Source: org_study_id
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