Trials / Unknown
UnknownNCT05220189
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
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,549 (estimated)
- Sponsor
- Asan Medical Center · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Patients with hematuria who are scheduled for cystoscopy will be asked to collect a urine sample for EarlyTect® Bladder Cancer test and will undergo NMP22 and urine cytology tests. The participants will undergo a cystoscopy within 30 days of enrollment. For confirmation of the diagnosis and stage of the tumor, representative histopathology slides from TURBT (Transurethral Resection of Bladder Tumors) may be retrieved and examined by the central pathology laboratory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | EarlyTect® Bladder Cancer test | A highly accurate and sensitive real-time PCR employing Linear Target Enrichment and Quantitative Methylation-Specific PCR (LTE-qMSP) for measuring PENK methylation in urine DNA to detect bladder cancer in hematuria patients. |
Timeline
- Start date
- 2022-02-03
- Primary completion
- 2023-12-31
- Completion
- 2024-01-31
- First posted
- 2022-02-02
- Last updated
- 2023-10-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05220189. Inclusion in this directory is not an endorsement.