An Investigation of the NMP22 Bladder Check Test for Early Detection of Bladder Cancer
The FDa has approved the nMP22 BladderChek Test for the diagnosis of bladder cancer in patients with risk factors or symptoms. The nMP22 BladderChek test provides results within 30 minutes and does not require a clinical laboratory for evaluation.
The primary objective of this study is to evaluate the performance of the nMP22 BladderChek Test for the early detection of bladder cancer in patients with a history of or presenting with gross or microscopic hematuria. The secondary objective of this study is to validate a bladder cancer detection nomogram based on clinical factors, urine cytology and the nMP22 test.
The study aims to prospectively enroll 300-500 male and female subjects. We have been asked to increase our number to 300.
every patient will have an nMP22 test and will undergo the current standard of care which may include cystoscopy, cytology and computed tomography or exretrory urogram. This will be done regardless of age, gender or other clinical factors such as smoking or environmental exposures.
1. Subject is willing and able to give written informed consent
2. Subject presents with or has a history of gross hematuria or microhematuria