Clinical Trial: Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer

Brief 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.

Detailed Summary:

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.


Sponsor: Medical Diagnostic Laboratories, LLC

Current Primary Outcome: Histology [ Time Frame: Up to 1 year after cystoscopy/biopsy ]

Original Primary Outcome:

Current Secondary Outcome:

  • Cystoscopy [ Time Frame: up to 3 months after collection ]
  • Cytology [ Time Frame: up to 3 months after collection ]


Original Secondary Outcome:

Information By: Medical Diagnostic Laboratories, LLC

Dates:
Date Received: March 23, 2012
Date Started: March 2012
Date Completion: December 2016
Last Updated: September 22, 2015
Last Verified: September 2015