Clinical trial NCT03125460: Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
Official title: Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Cepheid
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 424
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology clinics

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison to histology for positive or suspicious cystoscopy
timeFrame: Baseline = Subject Enrollment
measure: Comparison to histology for positive or suspicious cystoscopy
timeFrame: Follow up = 12 months from Subject Enrollment (Baseline)
Secondary outcomes:
measure: Comparison to UroVysion and urine cytology
timeFrame: Baseline = Subject Enrollment
measure: Comparison to UroVysion and urine cytology
timeFrame: Follow up = 12 months from Subject Enrollment (Baseline)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: PAVA
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado, P.C.
state: Colorado
city: Englewood
country: United States
facility: Urology Associates, P.C.
state: Colorado
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute
state: Idaho
city: Melrose Park
country: United States
facility: UroPartners
state: Illinois
city: Missoula
country: United States
facility: Five Valleys Urology
state: Montana
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre
state: Ontario
city: Burlington
country: Canada
facility: G Kenneth Jansz Medicine Professional Corp.
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates / Urologic Medical Research
state: Ontario
city: North Bay
country: Canada
facility: Urology Clinic of Dr. Goldfarb
state: Ontario
city: North York
country: Canada
facility: Urologic Clinic of Stanley Flax
state: Ontario
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
References: