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

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.

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