NCT00315653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 14, 2008

Status Verified

March 1, 2008

First QC Date

April 18, 2006

Last Update Submit

March 12, 2008

Conditions

Bladder Cancer

Keywords

Bladder CancerCancer of BladderBladder TumorsCancer of the BladderNeoplasms, Bladder

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Study Population

Subjects scheduled to undergo cystoscopy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujirebio Diagnostics, Inc

Malvern, Pennsylvania, 19355, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • William J Allard, PhD

    Fujirebio Diagnostics, Inc.

    STUDY DIRECTOR

  • Jose G Moreno, MD

    Tri County Urologic Associates, PC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

September 1, 2005

Study Completion

November 1, 2007

Last Updated

March 14, 2008

Record last verified: 2008-03

Locations

US(1)