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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01563796
Other study ID # ONC04
Secondary ID
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


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
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