Clinical trial NCT01563796: Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
Official title: A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematuria
Dysuria
Bladder Cancer
Keywords: bladder cancer
TCC
urine
protein ELISA
Lead sponsor: Medical Diagnostic Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients visiting urologist (primary care, referral, community, university or hospital).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Histology
timeFrame: Up to 1 year after cystoscopy/biopsy
Secondary outcomes:
measure: Cystoscopy
timeFrame: up to 3 months after collection
measure: Cytology
timeFrame: up to 3 months after collection
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Medical Diagnostic Laboratories, LLC
name: Jason Trama, PhD
role: STUDY_DIRECTOR
References:
citation: Datta A, Adelson ME, Mogilevkin Y, Mordechai E, Sidi AA, Trama JP. Oncoprotein DEK as a tissue and urinary biomarker for bladder cancer. BMC Cancer. 2011 Jun 10;11:234. doi: 10.1186/1471-2407-11-234.