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Survivin Urine mRNA Assay Risk of Bladder Cancer Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00315653
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : March 14, 2008
Sponsor:
Information provided by:
Fujirebio Diagnostics, Inc.

Tracking Information
First Submitted Date April 18, 2006
First Posted Date April 19, 2006
Last Update Posted Date March 14, 2008
Study Start Date September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Survivin Urine mRNA Assay Risk of Bladder Cancer Study
Official Title Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy
Brief Summary 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.
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 Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Subjects scheduled to undergo cystoscopy
Condition Bladder Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: April¬†18,¬†2006)
600
Original Enrollment Same as current
Actual Study Completion Date November 2007
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00315653
Other Study ID Numbers FDI-01 Sure Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jeff Allard, PhD, Fujirebio Diagnostics, inc
Study Sponsor Fujirebio Diagnostics, Inc.
Collaborators Not Provided
Investigators
Study Director: William J Allard, PhD Fujirebio Diagnostics, Inc.
Principal Investigator: Jose G Moreno, MD Tri County Urologic Associates, PC
PRS Account Fujirebio Diagnostics, Inc.
Verification Date March 2008