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A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer


N/A
25 Years
N/A
Open (Enrolling)
Both
Hematuria, Dysuria, Bladder Cancer

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Trial Information

A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer


Inclusion Criteria:



- Patients who are at least twenty-five (25) years of age with hematuria, dysuria or
other irritative voiding symptoms, without evidence of other causative factors such
as infections or stones.

Exclusion Criteria:

- Females who are pregnant (ascertained by history)

- Females who are menstruating or within three (3) days of their last menstruation

- Patients who have undergone invasive procedures of the urogenital tract in the past
two (2) months

- Patients with a history of transitional cell carcinoma (TCC) of the urinary tract

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Jason Trama, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Medical Diagnostic Laboratories, LLC

Authority:

United States: Institutional Review Board

Study ID:

ONC04

NCT ID:

NCT01563796

Start Date:

March 2012

Completion Date:

December 2013

Related Keywords:

  • Hematuria
  • Dysuria
  • Bladder Cancer
  • bladder cancer
  • TCC
  • urine
  • protein ELISA
  • Urinary Bladder Neoplasms
  • Dysuria
  • Hematuria

Name

Location

Staten Island University HospitalStaten Island, New York  10305