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

September 22, 2025 updated by: Medical Diagnostic Laboratories, LLC

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histology
Time Frame: Up to 1 year after cystoscopy/biopsy
Up to 1 year after cystoscopy/biopsy

Secondary Outcome Measures

Outcome Measure
Time Frame
Cystoscopy
Time Frame: up to 3 months after collection
up to 3 months after collection
Cytology
Time Frame: up to 3 months after collection
up to 3 months after collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Diagnostic Laboratories, LLC

Investigators

  • Study Director: Jason Trama, PhD, Medical Diagnostic Laboratories, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 15, 2016

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimated)

March 27, 2012

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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