Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer
1 other identifier
observational
424
3 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedFebruary 7, 2020
February 1, 2020
2.2 years
April 17, 2017
February 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison to histology for positive or suspicious cystoscopy
Comparison to histology for positive or suspicious cystoscopy
Baseline = Subject Enrollment
Comparison to histology for positive or suspicious cystoscopy
Comparison to histology for positive or suspicious cystoscopy
Follow up = 12 months from Subject Enrollment (Baseline)
Secondary Outcomes (2)
Comparison to UroVysion and urine cytology
Baseline = Subject Enrollment
Comparison to UroVysion and urine cytology
Follow up = 12 months from Subject Enrollment (Baseline)
Study Arms (2)
Initial Enrollment
Initial enrollment of patients with history of 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
Interventions
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
Eligibility Criteria
Urology clinics
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cepheidlead
Study Sites (17)
PAVA
Palo Alto, California, 94304, United States
The Urology Center of Colorado, P.C.
Denver, Colorado, 80211, United States
Urology Associates, P.C.
Englewood, Colorado, 80113, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Idaho Urologic Institute
Meridian, Idaho, 83642, United States
UroPartners
Melrose Park, Illinois, 60160, United States
Five Valleys Urology
Missoula, Montana, 59808, United States
Weill Cornell Medicine
New York, New York, 10065-4896, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
UT Southwestern
Dallas, Texas, 75390, United States
Virginia Urology
Richmond, Virginia, 23235, United States
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1 CA, Canada
G Kenneth Jansz Medicine Professional Corp.
Burlington, Ontario, L7N 3V2, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, N2N 2B9 CA, Canada
Urology Clinic of Dr. Goldfarb
North Bay, Ontario, P1B 7K8, Canada
Urologic Clinic of Stanley Flax
North York, Ontario, M2J 1V1, Canada
Radboud University Medical Center
Nijmegen, 6525GA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 24, 2017
Study Start
December 1, 2016
Primary Completion
February 1, 2019
Study Completion
May 1, 2019
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share