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

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ClinicalTrials.gov Identifier: NCT01563796
Recruitment Status : Unknown
Verified September 2015 by Medical Diagnostic Laboratories, LLC.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2012
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Medical Diagnostic Laboratories, LLC

March 23, 2012
March 27, 2012
September 24, 2015
March 2012
March 2014   (Final data collection date for primary outcome measure)
Histology [ Time Frame: Up to 1 year after cystoscopy/biopsy ]
Not Provided
Complete list of historical versions of study NCT01563796 on ClinicalTrials.gov Archive Site
  • Cystoscopy [ Time Frame: up to 3 months after collection ]
  • Cytology [ Time Frame: up to 3 months after collection ]
Not Provided
Not Provided
Not Provided
 
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With 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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
urine
Non-Probability Sample
patients visiting urologist (primary care, referral, community, university or hospital).
  • Hematuria
  • Dysuria
  • Bladder Cancer
Not Provided
  • TCC positive
    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
  • TCC negative
    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.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1000
Same as current
December 2016
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01563796
ONC04
No
Not Provided
Not Provided
Medical Diagnostic Laboratories, LLC
Medical Diagnostic Laboratories, LLC
Not Provided
Study Director: Jason Trama, PhD Medical Diagnostic Laboratories, LLC
Medical Diagnostic Laboratories, LLC
September 2015