TerminatedNot Applicable

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

Stopped: Business decision made not to pursue malignant disease diagnostic devices

United States1,115 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Histology

Timeframe: Up to 1 year after cystoscopy/biopsy

Trial details

NCT IDNCT01563796

SponsorMedical Diagnostic Laboratories, LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-10-01

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