Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 100
Updated:2/2/2019
Start Date:December 2016
End Date:March 2019
Contact:Andrew Hiar
Email:andrew.hiar@cepheid.com
Phone:847-228-3292

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Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer

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.


Inclusion Criteria:

- 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.
We found this trial at
12
sites
Richmond, Virginia 23235
Principal Investigator: Timothy Bradford, MD
Phone: 804-288-2785
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Missoula, Montana 59802
Principal Investigator: Karl Westenfelder, MD
Phone: 406-532-5676
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Missoula, MT
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411 Bayfield Street
Barrie, Ontario L4M 3C5
Principal Investigator: Joseph Zadra, MD
Phone: (705) 727-0551
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Barrie,
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Coeur d'Alene, Idaho 83814
Principal Investigator: Chad Peterson, MD
Phone: 208-415-1749
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Dallas, Texas 75390
Principal Investigator: Yair Lotan, MD
Phone: 214-645-8787
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Dallas, TX
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Denver, Colorado 80211
Principal Investigator: Laurence Karsh, MD
Phone: 303-762-7155
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Denver, CO
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Englewood, Colorado 80113
Principal Investigator: Barrett Cowan, MD
Phone: 303-733-8848
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Englewood, CO
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675 West North Avenue
Melrose Park, Illinois 60160
Principal Investigator: Richard Harris, MD
Phone: 708-681-4810
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Melrose Park, IL
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Meridian, Idaho 83642
Principal Investigator: Eric Klein, MD
Phone: 208-639-4946
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Meridian, ID
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New York, New York 10065
Principal Investigator: Douglas Scherr, MD
Phone: 212-746-4739
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New York, NY
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Oklahoma City, Oklahoma 73104
Principal Investigator: Sanjay Patel, MD
Phone: 405-271-8777
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Oklahoma City, OK
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3801 Miranda Avenue
Palo Alto, California 94304
Principal Investigator: Joseph Liao, MD
Phone: 650-849-1958
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Palo Alto, CA
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