Trovagene, Inc. (San Diego, CA, USA) and US Oncology Research (The Woodlands, TX, USA) have entered into a collaborative clinical study. They will examine the utility of quantitative urine-based KRAS mutation detection and monitoring in pancreatic cancer patients. 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 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 multisite study sponsored by Trovagene.
Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and clinical staff who specialize in Phase I through Phase IV oncology clinical trials. US Oncology Research serves more than 80 research sites and 225 locations managing about 225 active trials at any given time. Physicians in the research network have enrolled more than 56,000 patients in nearly 1,300 trials since inception in 1992 and have played a role in 47 US Food and Drug Association (FDA; Silver Spring, MD, USA)-approved cancer therapies.
Computed tomography (CT) scans and the tumor marker 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.
Dr. Daniel Von Hoff, Medical Director of Research and Scientific Medical Officer, McKesson Specialty Health and The US Oncology Network remarked, "We desperately need new ways to follow our patients with pancreatic cancer, particularly those without any other markers. He added, "It is important for our US Oncology Research team to be testing this new approach."
Antonius Schuh, PhD, president and CEO of Trovagene stated, "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 next-generation sequencing (NGS) assay, and is an important part of our strategic objective to integrate the use of our proprietary technology in clinical practice." He added, "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."
Pancreatic cancer is considered one of the most deadly cancers due to its aggressive nature and advanced stage at diagnosis. An estimated 80% of pancreatic cancer patients have unresectable or metastatic disease, and upward to 95% of pancreatic cancers are thought to have KRAS mutations. Based on these statistics, the need for an accurate, cost-effective test to quantify and monitor KRAS mutational status is high.
US Food and Drug Association
US Oncology Research