Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01563796
Study type	Observational
Source	Medical Diagnostic Laboratories, LLC
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 2012
Completion date	December 2016

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