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

• Sponsor: Cepheid (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03125460
• Collaborator: (none)
• Enrollment: 424
• Locations: 17
• Actual Duration (Months): 28.9
• Patients Per Site: 24.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Device: Xpert Bladder Cancer Monitor

Study Design

• Study Type: Observational
• Actual Enrollment: 424 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Initial Enrollment Initial enrollment of patients with history of bladder cancer	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
Longitudinal Cohort Longitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient	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

Outcome Measures

Primary Outcome Measures

1. Comparison to histology for positive or suspicious cystoscopy [Baseline = Subject Enrollment]

   Comparison to histology for positive or suspicious cystoscopy

2. 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

1. Comparison to UroVysion and urine cytology [Baseline = Subject Enrollment]

   Urovysion and urine cytology

2. Comparison to UroVysion and urine cytology [Follow up = 12 months from Subject Enrollment (Baseline)]

   Urovysion and urine cytology

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PAVA	Palo Alto	California	United States	94304
2	The Urology Center of Colorado, P.C.	Denver	Colorado	United States	80211
3	Urology Associates, P.C.	Englewood	Colorado	United States	80113
4	North Idaho Urology	Coeur d'Alene	Idaho	United States	83814
5	Idaho Urologic Institute	Meridian	Idaho	United States	83642
6	UroPartners	Melrose Park	Illinois	United States	60160
7	Five Valleys Urology	Missoula	Montana	United States	59808
8	Weill Cornell Medicine	New York	New York	United States	10065-4896
9	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104
10	UT Southwestern	Dallas	Texas	United States	75390
11	Virginia Urology	Richmond	Virginia	United States	23235
12	The Male/Female Health and Research Centre	Barrie	Ontario	Canada	L4M 7G1 CA
13	G Kenneth Jansz Medicine Professional Corp.	Burlington	Ontario	Canada	L7N 3V2
14	Urology Associates / Urologic Medical Research	Kitchener	Ontario	Canada	N2N 2B9 CA
15	Urology Clinic of Dr. Goldfarb	North Bay	Ontario	Canada	P1B 7K8
16	Urologic Clinic of Stanley Flax	North York	Ontario	Canada	M2J 1V1
17	Radboud University Medical Center	Nijmegen		Netherlands	6525GA

Sponsors and Collaborators

• Cepheid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cepheid
• ClinicalTrials.gov Identifier: NCT03125460
• Other Study ID Numbers: 170
• First Posted: Apr 24, 2017
• Last Update Posted: Feb 7, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Recurrence

Study Results

No Results Posted as of Feb 7, 2020