Evaluation for the clinical Performance of EarlyTect® Bladder Cancer Test for Detecting Bladder Cancer
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0007266
- Lead Sponsor
- Genomictree
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3753
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 1) Clinical sensitivity and specificity for detecting BC by EarlyTect® Bladder Cancer test as compared to NMP22 test 2) ?Clinical sensitivity and specificity for detecting BC by EarlyTect® Bladder Cancer test as compared to urine cytology