Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Urinary Bladder Neoplasms

Hematuria

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Urination Disorders

Hemorrhage

Device: EarlyTect Bladder Cancer test, PENK methylation assay by LTE (Linear Target Enrichment)-qMSP (quantitative methylation-specific real time PCR)

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.

EarlyTect® Bladder Cancer test

Cheol Kwak, MD PhD

In Gab Jeong, MD PhD

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.

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.

Residual urine samples may be archived for further research. Clinical data and samples will be kept in a manner that preserves anonymity of the subjects, using the subject ID as the only tracking information. Specimens will be stored at Genomictree and may be used for future research.

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

Comparison of clinical sensitivity and specificity to the NMP22 test

Comparison of clinical sensitivity and specificity to the urine cytology test

Sensitivity of EarlyTect® Bladder Cancer test for detecting bladder cancer with stages CIS and Ta low-grade

Positive predictive value and negative predictive value of EarlyTect® Bladder Cancer test for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and NMP22 tests for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer and cytology tests for detecting bladder cancer

Clinical sensitivity and specificity in the combination of EarlyTect® Bladder Cancer, NMP22, and cytology tests for detecting bladder cancer

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).

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PENK Methylation Test for Detecting Bladder Cancer	NCT05220189	Bladder Cancer Hematuria; Beni...	EarlyTect® Blad...	40 Years -	Asan Medical Center
PENK Methylation Test for Detecting Bladder Cancer	NCT05220189	Bladder Cancer Hematuria; Beni...	EarlyTect® Blad...	40 Years -	Asan Medical Center

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