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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical Diagnostic Laboratories, LLC
ClinicalTrials.gov Identifier:
NCT01563796
First received: March 23, 2012
Last updated: September 22, 2015
Last verified: September 2015
  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:


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

Primary Outcome Measures:
  • Histology [ Time Frame: Up to 1 year after cystoscopy/biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cystoscopy [ Time Frame: up to 3 months after collection ] [ Designated as safety issue: No ]
  • Cytology [ Time Frame: up to 3 months after collection ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
urine

Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: March 2014 (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.

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

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
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: September 22, 2015
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
Hematuria
Dysuria
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urination Disorders
Hemorrhage
Pathologic Processes
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 23, 2016