Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
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.
Sample Collection:

 Urine samples used in the study will be collected immediately prior to the urological
 evaluation procedure and stored at -80 oC. Urine samples will be sent to sponsor and remain
 at -80o C until analysis.

 Clinical Data Collection:

 All subject and clinical information will be recorded on the form in section 9.3. Enrollment
 Checklist and Case Report Form (CRF). Information regarding the history of hematuria and
 urine cytology will be recorded. In addition, non-identifying information including age, sex,
 race, smoking history, alcohol consumption, occupational exposure to chemicals or dyes,
 history of urologic disorder or disease, history of irritative voiding symptoms, history of
 urinary tract infection, history of pelvic irradiation, and analgesic abuse will be recorded.
 The Investigators will also be asked to provide information from the subjects' medical
 records for up to one (1) year after their enrollment and sample collection. In particular,
 diagnosis of TCC, other malignant diseases, or non-malignant urogenital conditions will be
 provided.
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