Bladder Cancer, Hematuria; Benign
Conditions
Keywords
Bladder cancer, Hematuria, Methylation biomarker, EarlyTect® Bladder Cancer test, Real-time PCR (LTE-qMSP), Urine
Brief 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.
Interventions
DIAGNOSTIC_TESTEarlyTect® 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.
Sponsors
Seoul National University Hospital
Korea University Anam Hospital
National Cancer Center, Korea
Pusan National University Hospital
Samsung Medical Center
Ajou University School of Medicine
Ulsan University Hospital
Chonnam National University Hospital
Seoul Clinical Laboratories
Seoul National University Bundang Hospital
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of the EarlyTect® Bladder Cancer test | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The performance of the EarlyTect® Bladder Cancer test | 1 year | The performance of the EarlyTect® Bladder Cancer test in detecting Bladder cancer in hematuria patients will be compared with those of the NMP22 and urine cytology tests. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of EarlyTect® Bladder Cancer test for detecting bladder cancer with stages CIS and Ta low-grade | 1 year | Sensitivity of EarlyTect® Bladder Cancer test for detecting bladder cancer with stages CIS and Ta low-grade |
| Positive predictive value (PPV) and Negative predictive value (NPV) | 1 year | Positive predictive value and negative predictive value of EarlyTect® Bladder Cancer test for detecting bladder cancer |
| Comparison of clinical sensitivity and specificity to the NMP22 test | 1 year | Comparison of clinical sensitivity and specificity to the NMP22 test |
| Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and cytology tests | 1 year | Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and cytology tests for detecting bladder cancer |
| Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer, NMP22, and cytology tests | 1 year | Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer, NMP22, and cytology tests for detecting bladder cancer |
| Evaluation of clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and NMP22 tests | 1 year | Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and NMP22 tests for detecting bladder cancer |
| Comparison of clinical sensitivity and specificity to the urine cytology test | 1 year | Comparison of clinical sensitivity and specificity to the urine cytology test |
Countries
South Korea
Contacts
Primary ContactCheol Kwak, MD PhD
Backup ContactIn Gab Jeong, MD PhD
Outcome results
None listed