KCT0007266
Recruiting
未知
A multicenter, single-blind, prospective clinical trial to evaluate the clinical performance of EarlyTect® Bladder Cancer test measuring PENK methylation in the urine DNA using real-time PCR for detecting bladder cancer among hematuria patients
Genomictree0 sites3,753 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Sponsor
- Genomictree
- Enrollment
- 3753
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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