Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Device: Xpert Bladder Cancer Monitor
- Registration Number
- NCT03125460
- Lead Sponsor
- Cepheid
- Brief Summary
The objective of this study is to establish the performance characteristics of an assay that detects the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. The study is conducted at locations within and outside of the United States. Testing is performed on urine specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 424
- Subject is ≥ 40 years of age
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Longitudinal Cohort Xpert Bladder Cancer Monitor Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient Initial Enrollment Xpert Bladder Cancer Monitor Initial enrollment of patients with history of bladder cancer
- Primary Outcome Measures
Name Time Method Comparison to histology for positive or suspicious cystoscopy Follow up = 12 months from Subject Enrollment (Baseline) Comparison to histology for positive or suspicious cystoscopy
- Secondary Outcome Measures
Name Time Method Comparison to UroVysion and urine cytology Follow up = 12 months from Subject Enrollment (Baseline) Urovysion and urine cytology
Trial Locations
- Locations (17)
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
UroPartners
🇺🇸Melrose Park, Illinois, United States
Urology Associates, P.C.
🇺🇸Englewood, Colorado, United States
Five Valleys Urology
🇺🇸Missoula, Montana, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
PAVA
🇺🇸Palo Alto, California, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Urology Clinic of Dr. Goldfarb
🇨🇦North Bay, Ontario, Canada
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
Urologic Clinic of Stanley Flax
🇨🇦North York, Ontario, Canada
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
The Urology Center of Colorado, P.C.
🇺🇸Denver, Colorado, United States