Survivin Urine mRNA Assay Risk of Bladder Cancer Study

This study has been completed.
Sponsor:
Information provided by:
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT00315653
First received: April 18, 2006
Last updated: March 12, 2008
Last verified: March 2008
  Purpose

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.


Condition
Bladder Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of the Survivin Urine mRNA Assay to Estimate Risk of Bladder Cancer Found on Cystoscopy

Resource links provided by NLM:


Further study details as provided by Fujirebio Diagnostics, Inc.:

Estimated Enrollment: 600
Study Start Date: September 2005
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

Subjects scheduled to undergo cystoscopy

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315653

Locations
United States, Pennsylvania
Fujirebio Diagnostics, Inc
Malvern, Pennsylvania, United States, 19355
Sponsors and Collaborators
Fujirebio Diagnostics, Inc.
Investigators
Study Director: William J Allard, PhD Fujirebio Diagnostics, Inc.
Principal Investigator: Jose G Moreno, MD Tri County Urologic Associates, PC
  More Information

No publications provided

Responsible Party: Jeff Allard, PhD, Fujirebio Diagnostics, inc
ClinicalTrials.gov Identifier: NCT00315653     History of Changes
Other Study ID Numbers: FDI-01 Sure Study
Study First Received: April 18, 2006
Last Updated: March 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Fujirebio Diagnostics, Inc.:
Bladder Cancer
Cancer of Bladder
Bladder Tumors
Cancer of the Bladder
Neoplasms, Bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014