DETECTION OF BLADDER CANCER AND RECURRENT BLADDER CANCER

摘要

The non-invasive methods described herein generally relates to methods of detecting bladder cancer or bladder cancer recurrence. The methods involve identifying a cutoff level for a protein biomarker parameter to provide a predetermined sensitivity for an assay, in which the measured biomarker parameter values below a defined cutoff level is indicative of the absence of cancer and measured biomarker parameter values above a defined cutoff level are indicative of the presence of cancer. The method can also involve establishing a cutoff level for two or more nucleic acid markers in which the nucleic acid markers increase the specificity of the assay without decreasing the sensitivity of the assay, and in which the cutoff level is indicative of the absence of cancer. Methods can further involve conducting an assay in a sample to determine a level of a protein marker and a level of a nucleic acid markers and identifying the sample as positive for cancer recurrence if the level of the protein marker and the nucleic acid markers are greater than their respective cutoff levels.

主权项

1. A method for detecting or predicting the likelihood of bladder cancer or recurrent bladder cancer in an individual comprising:
(a) obtaining a sample comprising at least one nucleic acid and at least one protein; (b) measuring the level of one or more nucleic acid biomarker parameters for one or more nucleic acid markers in said sample, wherein said nucleic acid markers comprise Vimentin, FGFR3, p53, TWIST1, or NID2; (c) measuring the level of one or more protein biomarker parameters for at least one or more protein markers in said sample, wherein said protein markers comprise MMP2 or MMP9; (d) determining whether said levels of nucleic acid or protein biomarker parameters exceed a preestablished cutoff level for each biomarker parameter; and (e) identifying an individual as having an increased likelihood of having bladder cancer or recurrent bladder cancer if at least one or more of the measured parameters are above said cutoff level and identifying an individual as having a decreased likelihood of having bladder cancer or recurrent bladder cancer if at least one or more of the measured parameters are below said cutoff level.