Microscopic or Gross HematuriaNCT00975455
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
An observational study of Microscopic or Gross Hematuria, run by Predictive Biosciences at 13 sites in United States.
Trial summary
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microscopic or Gross Hematuria
- How many people
- 1,400 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2009to Jan 2011
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from Urology and Oncology practices.
Who may be able to join
- For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
- Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
- Subject must have an intact bladder
- Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
- Subject must be able to provide a minimum of 25 mL of urine for study purposes.
- Urine samples must be available prior to cystoscopy, bladder biopsy, and TUR.
- Subjects must be willing to sign an Institutional Review Board approved written informed consent prior to any study related procedures being performed.
Who cannot join
- Subject had a history or current diagnosis of any basal or squamous cell cancer.
- Subject had a known diagnosis of any autoimmune disease.
- Subject had known diagnosis of HIV, HCV or HBV
- Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
- Subject is currently pregnant or lactating.
- Subject had surgery within 30 days prior to enrollment
- Subject has known allergy to benzalkonium chloride.
- Subject participated in an investigational drug or device trial within 30 days prior to enrollment.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
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
Eastern Urological Associates
Greenville, North Carolina, 27834
Metropolitan Urology
Jeffersonville, Indiana, 47130
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Associates in Urology
Orange, New Jersey, 07052
Winter Park Urology
Orlando, Florida, 32803
Hudson Valley Urology
Poughkeepsie, New York, 12601
Mayo Validation Support Services
Rochester, Minnesota, 55905
Urology San Antonio Research
San Antonio, Texas, 78229
About this study
Official title: Phase 3 Study of Hematuria Evaluation
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
- Conditions
- Microscopic or Gross Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with hematuria | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria
Measured: Initial Visit only
Secondary outcomes (1)
To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria.
Measured: Initial Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microscopic or Gross HematuriaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Predictive Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975455
- Sponsor's protocol ID
- PBS-002
- Status last verified
- Nov 2009
- First submitted
- 10 Sep 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 Hematuria Evaluation
- ClinicalTrials.gov ID
- NCT00975455
- Acronym / sponsor ID
- PBS-002
- Conditions
- Microscopic or Gross Hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Predictive BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 11 Sep 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 the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with hematuria | – | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from Urology and Oncology practices.
Key inclusion criteria (7 listed)
- For those subjects for whom there is no family history of bladder cancer or less than a 20 pack year history of cigarette smoking, subject must be 50 or older.
- Subject's age can be lowered to 45 or older if there is a family history of bladder cancer and/or a 20 or greater pack history of cigarette smoking.
- Subject must have an intact bladder
- Subject must be scheduled to have a cystoscopy to screen for transitional call bladder cancer due to the finding of hematuria.
- Subject must be able to provide a minimum of 25 mL of urine for study purposes.
Key exclusion criteria (8 listed)
- Subject had a history or current diagnosis of any basal or squamous cell cancer.
- Subject had a known diagnosis of any autoimmune disease.
- Subject had known diagnosis of HIV, HCV or HBV
- Subject had disclosed voluntarily history of or current infection with TB or other systemic disease.
- Subject is currently pregnant or lactating.
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
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria
Time frame: Initial Visit only
1 secondary outcome
To establish the performance characteristics of the PB assay relative to urine cytology results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria.
Time frame: Initial Visit
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.
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microscopic or Gross Hematuria, run by Predictive Biosciences at 13 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 7 inclusion and 8 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 13 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.
What does the primary outcome measure?
To establish the performance characteristics of the Predictive Biosciences Assay relative to the cystoscopy results for subjects undergoing evaluation for the referral diagnosis of gross or microscopic hematuria (time frame: Initial Visit only). 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 8 Jun 2011.