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


N/A
50 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

William J Allard, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Fujirebio Diagnostics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

FDI-01 Sure Study

NCT ID:

NCT00315653

Start Date:

September 2005

Completion Date:

November 2007

Related Keywords:

  • Bladder Cancer
  • Bladder Cancer
  • Cancer of Bladder
  • Bladder Tumors
  • Cancer of the Bladder
  • Neoplasms, Bladder
  • Urinary Bladder Neoplasms

Name

Location

Fujirebio Diagnostics, IncMalvern, Pennsylvania  19355