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

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.

Study Overview

• Status: Completed
• Conditions: Bladder Cancer
• Intervention / Treatment: Device: Xpert Bladder Cancer Monitor

• Study Type: Observational
• Enrollment (Actual): 424

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Urology clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison to UroVysion and urine cytology	Urovysion and urine cytology	Baseline = Subject Enrollment
Comparison to UroVysion and urine cytology	Urovysion and urine cytology	Follow up = 12 months from Subject Enrollment (Baseline)

Collaborators and Investigators

• Sponsor: Cepheid

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Recurrence; Urinary Bladder Neoplasms
• Other Study ID Numbers: 170 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No