Observational Study of Subjects Having Routine Recurrence Screening for Bladder Cancer

June 7, 2011 updated by: Predictive Biosciences

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

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.

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 (Anticipated)

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.
1000

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • BCG Oncology
    • Colorado
      • Engelwood, Colorado, United States, 80113
        • Urology Associates
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Orlando, Florida, United States, 32803
        • Winter Park Urology
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • Metropolitan Urology
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Validation Support Services
      • Woodbury, Minnesota, United States, 55125
        • Metro Urology
    • New Jersey
      • 741 Northfield Avenue, New Jersey, United States, 07052
        • Associates in Urology/Urology Group of NJ
      • Brick, New Jersey, United States, 08723
        • Coastal Urology Associates
    • New York
      • Albany, New York, United States, 12208
        • Community Care Physicians
      • Albany, New York, United States, 12208
        • Capital Regional Urological Surgeons
      • New York, New York, United States, 10016
        • University Urology Associates
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Urological Associates of Lancaster
      • Pittsburgh, Pennsylvania, United States, 15212
        • Triangle Urologic Group
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics of North Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be from urology and oncology practices

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

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.
Predictive Biosciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ellen Sheets, MD, Predictive Biosciences

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

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.
May 1, 2009

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.
April 1, 2010

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.
October 1, 2010

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).
May 14, 2009

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.
May 15, 2009

First Posted (Estimate)

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.
May 18, 2009

Study Record Updates

Last Update Posted (Estimate)

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.
June 8, 2011

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.
June 7, 2011

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.
November 1, 2009

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.
  • PBS-001

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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