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

February 6, 2020 updated by: Cepheid

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
424

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison to histology for positive or suspicious cystoscopy
Time Frame: Baseline = Subject Enrollment
Comparison to histology for positive or suspicious cystoscopy
Baseline = Subject Enrollment
Comparison to histology for positive or suspicious cystoscopy
Time Frame: Follow up = 12 months from Subject Enrollment (Baseline)
Comparison to histology for positive or suspicious cystoscopy
Follow up = 12 months from Subject Enrollment (Baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison to UroVysion and urine cytology
Time Frame: Baseline = Subject Enrollment
Urovysion and urine cytology
Baseline = Subject Enrollment
Comparison to UroVysion and urine cytology
Time Frame: Follow up = 12 months from Subject Enrollment (Baseline)
Urovysion and urine cytology
Follow up = 12 months from Subject Enrollment (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cepheid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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