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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125460
• Other study ID #: 170
• Status: Completed
• Start date: December 2016
• Est. completion date: May 2019

Study information

• Verified date: February 2020
• Source: Cepheid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: May 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Intervention

Device:
• Xpert Bladder Cancer Monitor
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer

Locations

Country	Name	City	State
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	Urology Clinic of Dr. Goldfarb	North Bay	Ontario
Canada	Urologic Clinic of Stanley Flax	North York	Ontario
Netherlands	Radboud University Medical Center	Nijmegen
United States	North Idaho Urology	Coeur d'Alene	Idaho
United States	UT Southwestern	Dallas	Texas
United States	The Urology Center of Colorado, P.C.	Denver	Colorado
United States	Urology Associates, P.C.	Englewood	Colorado
United States	UroPartners	Melrose Park	Illinois
United States	Idaho Urologic Institute	Meridian	Idaho
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	PAVA	Palo Alto	California
United States	Virginia Urology	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Cepheid

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison to histology for positive or suspicious cystoscopy	Comparison to histology for positive or suspicious cystoscopy	Baseline = Subject Enrollment
Primary	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	Comparison to UroVysion and urine cytology	Urovysion and urine cytology	Baseline = Subject Enrollment
Secondary	Comparison to UroVysion and urine cytology	Urovysion and urine cytology	Follow up = 12 months from Subject Enrollment (Baseline)