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CompletedNCT03125460Updated Feb 7, 2020

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

An observational study in Bladder Cancer, sponsored by Cepheid. Completed at 17 sites in 3 countries. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Cepheid · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
424
Ages
40 Years to 100 Years
Sex
All
01

Study 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.

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Conditions studied

  • Bladder Cancer
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In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's enrollment of 424 is above the median of 180 across 374 observational studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Cepheid is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Urology clinics

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 criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
424 participants (actual)
Patient registry
No

Groups and cohorts

  • Initial Enrollment

    Initial enrollment of patients with history of bladder cancer

    Device: Xpert Bladder Cancer Monitor

  • 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

Interventions

  • DeviceXpert Bladder Cancer Monitor

    in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer

06

What researchers measure

Primary outcomes

  1. Comparison to histology for positive or suspicious cystoscopy

    Comparison to histology for positive or suspicious cystoscopy

    Time frame: Baseline = Subject Enrollment

  2. Comparison to histology for positive or suspicious cystoscopy

    Comparison to histology for positive or suspicious cystoscopy

    Time frame: Follow up = 12 months from Subject Enrollment (Baseline)

Secondary outcomes

  1. Comparison to UroVysion and urine cytology

    Urovysion and urine cytology

    Time frame: Baseline = Subject Enrollment

  2. Comparison to UroVysion and urine cytology

    Urovysion and urine cytology

    Time frame: Follow up = 12 months from Subject Enrollment (Baseline)

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Study locations

17 sites
  • 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
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03125460
Lead sponsor
Cepheid
Responsible party
Sponsor
First posted
Apr 24, 2017
Start date
Dec 2016
Primary completion
Feb 2019
Completion
May 2019
Last update
Feb 7, 2020

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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