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|
- Histology [ Time Frame: Up to 1 year after cystoscopy/biopsy ] [ Designated as safety issue: No ]
- Cystoscopy [ Time Frame: up to 3 months after collection ] [ Designated as safety issue: No ]
- Cytology [ Time Frame: up to 3 months after collection ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||March 2014 (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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563796
|United States, New York|
|Staten Island University Hospital|
|Staten Island, New York, United States, 10305|
|Study Director:||Jason Trama, PhD||Medical Diagnostic Laboratories, LLC|