Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
Conditions
Hematuria - Dysuria - Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
bladder cancer, TCC, urine, protein ELISA
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer. The measurement of urine DEK protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 25 Years
Gender: Both
Criteria: 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
Location
Staten Island University Hospital
Staten Island, New York, United States
Status: Recruiting
Start Date
March 2012
Completion Date
December 2013
Sponsors
Medical Diagnostic Laboratories, LLC
Source
Medical Diagnostic Laboratories, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page