Bladder Cancer RecurrenceNCT00903240
Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer
An observational study of Bladder Cancer Recurrence, run by Predictive Biosciences at 20 sites in United States.
Trial summary
The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Recurrence
- How many people
- 1,000 participants
- Where
- 20 sitesUnited States
- Study dates
- May 2009to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be from urology and oncology practices
Who may be able to join
- Intact bladder
- Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening
- Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR
- Must be willing to sign IRB approved informed consent
Who cannot join
- History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer
- Known diagnosis of any autoimmune disease or HIV, HCV or HBV
- History or current TB or any other active infection
- Subject has gross hematuria
- Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment
- Any surgery except urologic within past 30 days
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Associates in Urology/Urology Group of NJ
741 Northfield Avenue, New Jersey, 07052
Capital Regional Urological Surgeons
Albany, New York, 12208
Community Care Physicians
Albany, New York, 12208
Coastal Urology Associates
Brick, New Jersey, 08723
The Urology Group
Cincinnati, Ohio, 45212
Urology Clinics of North Texas
Dallas, Texas, 75231
Atlantic Urological Associates
Daytona Beach, Florida, 32114
Urology Associates
Engelwood, Colorado, 80113
Metropolitan Urology
Jeffersonville, Indiana, 47130
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17601
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
University Urology Associates
New York, New York, 10016
Winter Park Urology
Orlando, Florida, 32803
BCG Oncology
Phoenix, Arizona, 85032
Triangle Urologic Group
Pittsburgh, Pennsylvania, 15212
Hudson Valley Urology
Poughkeepsie, New York, 12601
Mayo Validation Support Services
Rochester, Minnesota, 55901
Urology San Antonio Research
San Antonio, Texas, 78229
Associated Medical Professionals
Syracuse, New York, 13210
Metro Urology
Woodbury, Minnesota, 55125
About this study
Official title: Phase 3 Study of Bladder Cancer Recurrence Surveillance
The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine
- Conditions
- Bladder Cancer Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer RecurrenceStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Predictive Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ellen Sheets, MD, Study director, Predictive Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903240
- Sponsor's protocol ID
- PBS-001
- Status last verified
- Nov 2009
- First submitted
- 14 May 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Bladder Cancer Recurrence Surveillance
- ClinicalTrials.gov ID
- NCT00903240
- Acronym / sponsor ID
- PBS-001
- Conditions
- Bladder Cancer Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Predictive BiosciencesIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 18 May 2009 (estimated)
- 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 purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be from urology and oncology practices
Key inclusion criteria (4 listed)
- Intact bladder
- Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening
- Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR
- Must be willing to sign IRB approved informed consent
Key exclusion criteria (6 listed)
- History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer
- Known diagnosis of any autoimmune disease or HIV, HCV or HBV
- History or current TB or any other active infection
- Subject has gross hematuria
- Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 8 Jun 2011.
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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
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Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
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Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
High-risk Non-muscle Invasive Bladder Cancer
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.
Ellen Sheets, MD study director
Predictive Biosciences
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer Recurrence, run by Predictive Biosciences at 20 sites in United States.
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 4 inclusion and 6 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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.
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 8 Jun 2011.