M2GEN-supported research network ORIEN® begins COVID-19 study in cancer patients funded through the ORIEN Foundation
TAMPA, Fla., Oct. 1, 2020 /PRNewswire/ -- The Oncology Research Information Exchange Network (ORIEN), an alliance of 18 of the top national cancer centers, announced today the initiation of a COVID-19 study in cancer patients funded through the ORIEN Foundation. ORIEN members have the unique potential to contribute significantly to understanding not only the short-term effects of COVID-19, but also possible long-term effects on survivors that may affect cancer patient outcomes.
Researchers from ORIEN Member cancer centers around the country will conduct a case-control study sampled from patients currently enrolled in the Total Cancer Care® (TCC) Protocol. Under M2Gen's unique and proprietary TCC Protocol, patients consent to be followed over the course of their lifetime, donate their clinical data and tissue, and agree to be re-contacted, thus enabling longitudinal observational research studies. This approach aims to advance science and research, and accelerate the development of novel cancer therapies and personalized medicines. The COVID-19 study will include a subset of those patients for which both deep clinical and molecular data sets (derived from both tumor and normal germline specimens) have previously been generated, known as ORIEN Avatar®. All patients with a diagnosed COVID-19 infection will be included as cases and controls will be matched 1:1 from ORIEN Avatar participants without COVID-19 infection. The primary outcome of interest is 30 day overall survival, with secondary outcomes including one year overall survival, progression free survival and guideline concordant treatment. In addition, genomic and clinical factors predictive of COVID-19 outcomes and patient reported outcomes will be evaluated.
"With the emergence of COVID-19 over the last year, there is very little evidence describing the natural history of patients with cancer and COVID-19 disease associated with the SARS-CoV-2 coronavirus (SCV-2). However, it is anticipated that they are both more susceptible and experience more severe infections with worse clinical outcomes than those without cancer," said Jill Kolesar, PharmD, Professor, Colleges of Pharmacy and Medicine, University of Kentucky.
With the limited amount of data available, patients and providers are faced with daily decisions on whether to proceed with cancer treatments or delay them in hopes of minimizing exposure to COVID-19 infection. Studies from retrospective observational cohorts report increased frequency of infection in patients with cancer although as of yet there is no data to suggest that patients with cancer experience worse outcomes than those without. To date, most if not all of the cohort studies do not collect genomic data. However, assessment of molecular biomarkers for infection risk and patient outcomes maybe beneficial and valuable to better manage patients with cancer during the pandemic. Experts express an urgent need for long term follow-up patient data with comparison cohorts and genomic data to understand the factors associated with infection risk and clinical outcomes.
"We are honored that the donors to the ORIEN Foundation were willing to support ORIEN's COVID-19 research project, and grateful to M2GEN for their continued efforts to support collaborative research not only in the oncology field but in timely real-world data endeavors that will have an impact on healthcare worldwide," said William Dalton, PhD, MD, Founder and Executive Chair of M2GEN.
"This project again demonstrates the power and value of the ORIEN and the Total Cancer Care Protocol. As all ORIEN Members have deployed the TCC Protocol, the network can swiftly generate and analyze patient data and outcomes to provide evidence that will enhance our understanding of COVID-19 in relation to underlying conditions and genetic predispositions in cancer patients," Helge Bastian, PhD, President & CEO of M2GEN added. "We are extremely thankful to the donors to the ORIEN Foundation who facilitate conducting these important collaborative research studies by leveraging our unique oncology network."
As of today, participating ORIEN Members include: Markey Cancer Center of The University of Kentucky, University of Virginia Health System Cancer Center, University of Colorado Cancer Center, Rutgers-Cancer Institute of New Jersey, Roswell Park Comprehensive Cancer Center, Dartmouth-Hitchcock Norris Cotton Cancer Center, USC Norris Comprehensive Cancer Center, University of Iowa Holden Comprehensive Cancer Center, Huntsman Cancer Institute, Winship Cancer Institute of Emory University, Indiana University Melvin and Bren Simon Comprehensive Cancer Center
If you are interested in supporting the ORIEN Foundation's effort to accelerate cancer research, please visit the Community Foundation of Tampa Bay website: https://cftampabay.org/give_now/orien/
ORIEN Members are some of the nation's leading cancer institutions that recognize collaboration and access to data are the keys to cancer discovery. There are currently 18 Cancer Center members working together to leverage multiple data sources and match patients to targeted treatments. To view the current member list and learn more about their research and impact, visit oriencancer.org.
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