Study to validate test for bladder cancer recurrence

The National Cancer Institute began a 3-year study to validate a test that detects bladder cancer recurrence. The phase III study will be conducted at 12 centers across the United States and Canada.

NCI's Early Detection Research Network conceived the test, which uses microsatellite DNA analysis (MSA). When screening for recurrent bladder cancer, DNA can be extracted from cells in urine and compared with DNA sequences of unaffected cells from the same patient. Early studies have shown this noninvasive analysis can be over 90% accurate.

The validation study will review 15 different biomarkers in 300 patients diagnosed with bladder cancer. Controls will be individuals with healthy bladders and individuals with non-cancerous bladder problems that could be misdiagnosed as cancer.

"The primary goal of this study is to monitor MSA for bladder cancer recurrence," said Sudhir Srivastava, PhD, of NCI's Division of Cancer Prevention, "but the longer goal is to also use the test for early detection of new bladder cancer occurrence."

Final results are expected in September 2007. After phase III validation, Cangen Biotechnologies Inc., which holds the license for the MSA test, plans to seek FDA approval for public distribution.