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 range

25 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Hematuria trials

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

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