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

This study is currently recruiting participants.
Verified March 2012 by Medical Diagnostic Laboratories, LLC
Sponsor:
Information provided by (Responsible Party):
Medical Diagnostic Laboratories, LLC
ClinicalTrials.gov Identifier:
NCT01563796
First received: March 23, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition
Hematuria
Dysuria
Bladder Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Diagnostic Laboratories, LLC:

Biospecimen Retention:   None Retained

urine


Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients visiting urologist (primary care, referral, community, university or hospital).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563796

Contacts
Contact: Jason Trama, PhD 6095701015 ext 1036 jtrama@oncoveda.com

Locations
United States, New York
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Principal Investigator: Nachum M Katlowitz, MD            
Sponsors and Collaborators
Medical Diagnostic Laboratories, LLC
Investigators
Study Director: Jason Trama, PhD Medical Diagnostic Laboratories, LLC
  More Information

Publications:

Responsible Party: Medical Diagnostic Laboratories, LLC
ClinicalTrials.gov Identifier: NCT01563796     History of Changes
Other Study ID Numbers: ONC04
Study First Received: March 23, 2012
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical Diagnostic Laboratories, LLC:
bladder cancer
TCC
urine
protein ELISA

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Dysuria
Hematuria
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urination Disorders
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013