Status:
UNKNOWN
PENK Methylation Test for Detecting Bladder Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Korea University Anam Hospital
Conditions:
Bladder Cancer
Hematuria; Benign
Eligibility:
All Genders
40+ years
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 t...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2024
Estimated Enrollment :
1549 Patients enrolled
Trial Details
Trial ID
NCT05220189
Start Date
February 3 2022
End Date
January 31 2024
Last Update
October 4 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505