Bladder CancerNCT03125460
Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
An observational study of Bladder Cancer, run by Cepheid at 17 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Xpert Bladder Cancer Monitor
- Type of treatment
- Medical device
- How many people
- 424 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Dec 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Urology clinics
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States11 sites
North Idaho Urology
Coeur d'Alene, Idaho, 83814
UT Southwestern
Dallas, Texas, 75390
The Urology Center of Colorado, P.C.
Denver, Colorado, 80211
Urology Associates, P.C.
Englewood, Colorado, 80113
UroPartners
Melrose Park, Illinois, 60160
Idaho Urologic Institute
Meridian, Idaho, 83642
Five Valleys Urology
Missoula, Montana, 59808
Weill Cornell Medicine
New York, New York, 10065-4896
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
PAVA
Palo Alto, California, 94304
Virginia Urology
Richmond, Virginia, 23235
Canada5 sites
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1 CA
G Kenneth Jansz Medicine Professional Corp.
Burlington, Ontario, L7N 3V2
Urology Associates / Urologic Medical Research
Kitchener, Ontario, N2N 2B9 CA
Urology Clinic of Dr. Goldfarb
North Bay, Ontario, P1B 7K8
Urologic Clinic of Stanley Flax
North York, Ontario, M2J 1V1
About this study
Official title: 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.
- Conditions
- Bladder Cancer
- Being tested
- Xpert Bladder Cancer Monitor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert Bladder Cancer MonitorDevice
in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
| Study group | Role | What they receive |
|---|---|---|
| Initial Enrollment | Initial enrollment of patients with history of bladder cancer Receives: 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 Receives: Device: Xpert Bladder Cancer Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison to histology for positive or suspicious cystoscopy
Comparison to histology for positive or suspicious cystoscopy
Measured: Baseline = Subject Enrollment
Comparison to histology for positive or suspicious cystoscopy
Comparison to histology for positive or suspicious cystoscopy
Measured: Follow up = 12 months from Subject Enrollment (Baseline)
Secondary outcomes (2)
Comparison to UroVysion and urine cytology
Urovysion and urine cytology
Measured: Baseline = Subject Enrollment
Comparison to UroVysion and urine cytology
Urovysion and urine cytology
Measured: Follow up = 12 months from Subject Enrollment (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study startDec 2016
- Primary completionFeb 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125460
- Sponsor's protocol ID
- 170
- Status last verified
- Feb 2020
- First submitted
- 17 Apr 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Xpert Bladder Cancer Monitor for Monitoring the Recurrence of Bladder Cancer
- ClinicalTrials.gov ID
- NCT03125460
- Acronym / sponsor ID
- 170
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Enrollment | – | Device: Xpert Bladder Cancer MonitorInitial enrollment of patients with history of bladder cancer |
| Longitudinal Cohort | – | Device: Xpert Bladder Cancer MonitorLongitudinal Cohort - patients considered anticipatory positive at the time of enrollment and one random disease negative patient per anticipatory positive patient |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology clinics
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert Bladder Cancer Monitorin vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer | Device | Initial Enrollment, Longitudinal Cohort |
Primary outcome
Comparison to histology for positive or suspicious cystoscopy
Time frame: Baseline = Subject Enrollment
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)
Comparison to histology for positive or suspicious cystoscopy
2 secondary outcomes
Comparison to UroVysion and urine cytology
Time frame: Baseline = Subject Enrollment
Comparison to UroVysion and urine cytology
Time frame: Follow up = 12 months from Subject Enrollment (Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Cepheid at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison to histology for positive or suspicious cystoscopy (time frame: Baseline = Subject Enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.