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

Bladder Cancer Clinical Trial

Official title:

A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01563796
• Other study ID #: ONC04
• Status: Active, not recruiting
• Phase: N/A
• First received: March 23, 2012
• Last updated: September 22, 2015
• Start date: March 2012
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Medical Diagnostic Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bladder Cancer
• Dysuria
• Hematuria
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medical Diagnostic Laboratories, LLC

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histology		Up to 1 year after cystoscopy/biopsy	No
Secondary	Cystoscopy		up to 3 months after collection	No
Secondary	Cytology		up to 3 months after collection	No