Trovagene, a San Diego, Calif.-based developer of cell-free molecular diagnostics, and U.S. Oncology Research, a community-based research program in the U.S., have entered into a Clinical Study Agreement to examine the utility of quantitative urine-based KRAS mutation detection and monitoring in pancreatic cancer patients.

U.S. Oncology Research draws from a network of experienced investigators and clinical staff who specialize in phase I through phase IV oncology clinical trials.

Metastatic pancreatic cancer frequently is associated with KRAS gene mutations. The primary purpose of the 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 currently are the only two methods available to clinicians to monitor metastatic pancreatic cancer tumor burden and response to therapy.

However, approximately 11% to 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.

"We desperately need new ways to follow our patients with pancreatic cancer, particularly those without any other markers," said Dr. Daniel Von Hoff, medical director of research and scientific medical officer, McKesson Specialty Health and the U.S. Oncology Network.

"The study is designed to provide comprehensive qualitative and quantitative clinical results for our multiplexed KRAS NGS assay, and is an important part of our strategic objective to integrate the use of our proprietary technology in clinical practice," said Antonius Schuh, Ph.D., president and CEO of Trovagene. "We believe that near real-time detection and monitoring of KRAS mutations in metastatic cancer patients have potential to improve patient outcomes and impact the standard of care for cancer monitoring."