Clinical trial · Observational
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
A Multi-Center Study to Evaluate the Safety and Efficacy of a Urine DEK ELISA in Diagnosis of Subjects With Bladder Cancer
NCT01563796CI-TRIAL-00095856terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision made not to pursue malignant disease diagnostic devices
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Dysuria | — | UNRESOLVED | — |
| Hematuria | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- TCC positive
- description
- subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to have a bladder tumor confirmed by histopathology
- label
- TCC negative
- description
- subjects with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones that are found to NOT have a bladder tumor by histopathology or clinical observation.
Primary outcomes (1)
- measure
- Histology
- timeFrame
- Up to 1 year after cystoscopy/biopsy
Secondary outcomes (2)
- measure
- Cystoscopy
- timeFrame
- up to 3 months after collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDDatta 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. PMID 21663673