Trovagene, Inc. and US Oncology Research have 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.
"We desperately need new ways to follow our patients with pancreatic cancer, particularly those without any other markers," stated Dr. Daniel Von Hoff, Medical Director of Research and Scientific Medical Officer, McKesson Specialty Health and The US Oncology Network. "It is important for our US Oncology Research team to be testing this new approach."
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.
"We are pleased to be collaborating with US Oncology Research and its network of community cancer care sites. 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," stated Antonius Schuh, Ph.D., President and CEO of Trovagene.
Schuh continued, "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."