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Trial Title:
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
NCT ID:
NCT01563796
Condition:
Hematuria
Dysuria
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Hematuria
Dysuria
Conditions: Keywords:
bladder cancer
TCC
urine
protein ELISA
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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.
Criteria for eligibility:
Study pop:
patients visiting urologist (primary care, referral, community, university or hospital).
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
25 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Staten Island University Hospital
Address:
City:
Staten Island
Zip:
10305
Country:
United States
Start date:
March 2012
Completion date:
December 2016
Lead sponsor:
Agency:
Medical Diagnostic Laboratories, LLC
Agency class:
Industry
Source:
Medical Diagnostic Laboratories, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01563796
