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

NCT01563796 | Terminated

• 1 other identifier: ONC04
• Study Type: observational
• Target: 1,115
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria; Dysuria; Bladder Cancer

Keywords

bladder cancer; TCC; urine; protein ELISA

Outcome Measures

Primary Outcomes (1)

• Histology

  Up to 1 year after cystoscopy/biopsy

Secondary Outcomes (2)

• Cystoscopy

  up to 3 months after collection

• Cytology

  up to 3 months after collection

Study Arms (2)

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 Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Diagnostic Laboratories, LLC: lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Related Publications (1)

• 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.

  PMID: 21663673 BACKGROUND

MeSH Terms

Conditions

Hematuria; Dysuria; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases

Study Officials

• Jason Trama, PhD

  Medical Diagnostic Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 15, 2016
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)