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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
- 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
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