Trovagene, Inc. and US Oncology Research announced that they have entered into a Clinical Study Agreement to examine the utility of quantitative urine-based KRAS mutation detection and monitoring in pancreatic cancer patients. US Oncology Research draws from a network of experienced investigators and clinical staff who specialize in Phase I through Phase IV oncology clinical trials. In addition to the 11 US Oncology Research affiliated community cancer care sites participating in this study, academic research institutions that specialize in oncology have also elected to participate.

Metastatic pancreatic cancer is frequently associated with KRAS gene mutations. The primary purpose of the collaborative study is to determine whether KRAS mutations can be evaluated in urine to monitor treatment response in patients that test either positive or negative for the tumor marker CA19-9. CT scans and CA19-9 blood levels are currently the only two methods available to clinicians to monitor metastatic pancreatic cancer tumor burden and response to therapy. However, approximately 11%-17% of patients will not display elevated CA 19-9, even with high tumor load.

For patients that test negative for CA19-9, Trovagene's method to follow disease status could be distinctly beneficial. Patient enrollment is expected to begin in the first quarter of 2014, and up to 45 patients are expected to participate in the collaborative study. The prospective study supports Trovagene's core objective to demonstrate the clinical value of its proprietary cell-free DNA platform for the detection and monitoring of oncogene mutations in urine.

In addition to other clinical studies evaluating Trovagene's novel molecular diagnostics, the US Oncology Research collaboration is the first multi-site study sponsored by Trovagene.