Clinical trial · Observational
PENK Methylation Test for Detecting Bladder Cancer
A Multicenter, Single-blind, Prospective Clinical Trial to Evaluate the Clinical Performance of EarlyTect® Bladder Cancer Test in the Urine DNA for Detecting Bladder Cancer Among Hematuria Patients
NCT05220189CI-TRIAL-00070172unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® Bladder Cancer test for bladder cancer among patients with hematuria by comparing it to the results of cystoscopy examinations. The second objective is to compare the clinical performance of EarlyTect® Bladder Cancer test with a NMP22 test and urine cytology test with respect to bladder cancer. By histopathological examination, lesions identified during cystoscopy will be confirmed as malignant or non-malignant by histological examination.
Conditions
Conditions (2)
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 |
| Hematuria; Benign | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EarlyTect® Bladder Cancer test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hematuria patients aged ≥40
- description
- Device: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR)
- interventionNames
- Diagnostic Test: EarlyTect® Bladder Cancer test
Primary outcomes (1)
- measure
- Sensitivity and specificity of the EarlyTect® Bladder Cancer test
- timeFrame
- 1 year
- description
- Sensitivity and specificity of the EarlyTect® Bladder Cancer test for detecting bladder cancer (Stages Ta high-grade and T1-T4) in patients with hematuria compared to the cystoscopy examination, both in terms of detecting bladder cancer. The reference method is the cystoscopic procedure, and lesions will be assessed histopathologically. EarlyTect® Bladder Cancer test includes a measurement of PENK methylation and COL2A1 as a DNA control. PENK methylation in urine DNA will be assessed quantitatively by Linear Target Enrichment-coupled Quantitative Methylation-Specific PCR (LTE-qMSP) using the Real-time PCR method. The results will be dichotomized by the CT (cycle threshold) cutoff value as either positive or negative. Sensitivity = 100\*(positive PENK methylation test/positive cystoscopy), Specificity = 100\*(negative PENK methylation test/negative cystoscopy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Individuals who agree to voluntarily sign an informed consent prior to the initiation of screening * Adults aged ≥40 * Subjects who have had gross or microscopic hematuria within the 3 months * Subjects who had no history of bladder cancer and upper tract urothelial cancer * Subjects who will undergo cystoscopy, NMP22 test, and urine cytology within 1 month after consent Exclusion Criteria: * Individuals who do not agree to voluntarily sign an informed consent prior to the initiation of screening * Subjects aged \<40 years * Subjects with a history of bladder cancer and upper tract urothelial cancer * Female who are currently menstruating or who have had their last menstrual period within the last 3 days * Subjects who have undergone invasive procedures in the urinary tract system within the last 3 months * Subjects with suspected upper urothelial cancer lesions on ultrasound or CT scan * Subjects who have previously received pelvic radiation therapy * Subjects who have been diagnosed with other cancers and have received or are currently receiving chemotherapy or immunotherapy within 6 months * Subjects who require treatment for an active urinary tract infection or vaginitis * Subjects undergoing prostate cancer treatment or requiring a prostate biopsy * Subject has any condition which, in the opinion of the investigator should preclude participation in the study
References
Publications (1)
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