Survivin Urine mRNA Assay Risk of Bladder Cancer Study

March 12, 2008 updated by: Fujirebio Diagnostics, Inc.

Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy

The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.

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.

Detailed Description

Bladder cancer is the fourth most common cancer in men and ninth most common cancer in women, accounting for more than 60,000 new cases and ~12,000 deaths in North America in 2004. Cystoscopy and urinary cytology is the standard of care for detection of bladder cancer, but cystoscopy is expensive and invasive, while cytology has low sensitivity. New, noninvasive, diagnostic tools for bladder cancer detection have been developed, but their application in clinical practice has been limited due to low sensitivity and specificity of the assays. Survivin, an anti-apoptotic protein, is capable of regulating both cell proliferation and apoptotic cell death, and is over-expressed in most human cancers but not in normal adult tissues. The purpose of this clinical trial is to evaluate the ability of urinary Survivin mRNA measurement to estimate the risk of bladder cancer at the time of cystoscopy in subjects with no prior history of bladder cancer presenting with microscopic or macroscopic hematuria.

This study is designed to be a prospective, multicenter, double blind, clinical study in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria (microscopic and/or macroscopic) presenting to a urologist.

The primary objective of the study is to estimate the risk of bladder cancer at the time of cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria using urinary Survivin mRNA levels.

The secondary objective of the study is for comparison of a multivariate predictive algorithm using urinary Survivin mRNA levels and subject risk factors, such as age, sex, race, and smoking history, for estimation of the risk of bladder cancer at the time of cystoscopy in subjects >50 years old with no prior history of bladder cancer and confirmed hematuria to the use of urinary Survivin mRNA levels alone.

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

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.
600

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
    • Pennsylvania
      • Malvern, Pennsylvania, United States, 19355
        • Fujirebio Diagnostics, Inc

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

Subjects scheduled to undergo cystoscopy

Description

Inclusion Criteria:

  • Able to understand and sign Informed Consent;
  • Age >50 years old;
  • Males or females;
  • Subjects must have confirmed micro-hematuria, defined as any positive urine reagent strip test for blood (i.e. finding of "Trace" or higher amounts of blood) and/or >3 RBC per high power field on microscopic examination, or macro-hematuria, defined as visible blood in the urine sample;
  • All subjects must be scheduled to undergo a cystoscopy evaluation;
  • All subjects must have upper tract imaging performed within +/- 4 weeks of the cystoscopic evaluation.

Exclusion Criteria:

  • Previous history of bladder cancer;
  • Previous history of other cancers except for non-melanoma skin cancer;
  • Prior pelvic radiation;
  • Active urinary or vaginal infection;
  • Any evidence of vaginal or rectal bleeding;
  • Currently receiving chemotherapies such as cyclophosphamide or methotrexate;
  • Unable to provide informed consent or a high risk that the subject may not comply with the protocol requirements.

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.
Fujirebio Diagnostics, Inc.

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: William J Allard, PhD, Fujirebio Diagnostics, Inc.
  • Principal Investigator: Jose G Moreno, MD, Tri County Urologic Associates, PC

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.
September 1, 2005

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.
November 1, 2007

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).
April 18, 2006

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.
April 18, 2006

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.
April 19, 2006

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.
March 14, 2008

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.
March 12, 2008

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.
March 1, 2008

More Information

Terms related to this study

Keywords

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.
  • FDI-01 Sure Study

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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