Overview

This trial is active, not recruiting.

Conditions hematuria, dysuria, bladder cancer
Sponsor Medical Diagnostic Laboratories, LLC
Start date March 2012
End date March 2014
Trial size 1000 participants
Trial identifier NCT01563796, ONC04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
Histology
time frame: Up to 1 year after cystoscopy/biopsy

Secondary Outcomes

Measure
Cystoscopy
time frame: up to 3 months after collection
Cytology
time frame: up to 3 months after collection

Eligibility Criteria

Male or female participants at least 25 years old.

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

Additional Information

Official title A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Medical Diagnostic Laboratories, LLC.