Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer|
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to have a bladder tumor confirmed by histopathology
subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to NOT have a bladder tumor by histopathology or clinical observation.
|Contact: Jason Trama, PhD||6095701015 ext email@example.com|
|United States, New York|
|Staten Island University Hospital||Recruiting|
|Staten Island, New York, United States, 10305|
|Principal Investigator: Nachum M Katlowitz, MD|
|Study Director:||Jason Trama, PhD||Medical Diagnostic Laboratories, LLC|