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 个研究点目标入组 3,753 人开始时间: 待定最近更新: 2022年5月30日

适应症

试验速览

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•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

发起方

Genomictree