The Prospective Clinico-Genomic Study aims to understand the cancer patient journey at scale by linking real-world clinical outcomes with genomic data, clinical images, and digital pathology data
NEW YORK, NY
Flatiron Health, Foundation Medicine, and Genentech, a member of the Roche Group, in partnership with community and academic oncology practices, have launched the Prospective Clinico-Genomic (PCG) Study, NCT04180176. PCG is a novel, low-interventional study that will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline and simplify the execution of clinical trials for patients living with advanced lung cancer.
The PCG Study, funded and sponsored by Genentech, is a feasibility study with secondary aims to better understand how genomic changes in a patient’s tumor may predict response or impact resistance to treatment in people diagnosed with metastatic non-small cell lung cancer or extensive stage small cell lung cancer by building a linked data- and bio-repository. Flatiron’s prospective real-world data collection technology will be leveraged for this study, which will enroll approximately 1,000 patients. These patients will undergo serial liquid biopsies using Foundation Medicine’s liquid biopsy assay to assess genomic changes in their cancer over the course of treatment. Leveraging technology developed following years of collaboration between Flatiron and Foundation Medicine, the clinical, genomic, imaging and outcomes data will be a part of a comprehensive data platform that is designed to accelerate research, a central part of Roche’s vision for personalized healthcare.
“Through technology-driven innovation, we have realized our vision of building a platform that enables meaningful clinical research while also minimizing the burden on clinicians and research teams. This includes features such as centralized and remote study monitoring, streamlined patient identification, and technology-assisted abstraction to eliminate duplicate data entry and the need to use a separate electronic data capture system,” said Dr. Bobby Green, chief medical officer at Flatiron Health. “Our goal is to bring vital clinical research to patients where their care is already being delivered, and to do so efficiently and seamlessly.”
Since launching the study in December 2019, 14 practices from Flatiron’s network have been activated: Alabama Oncology, Cancer & Hematology Centers of Western Michigan, Clearview Cancer Institute, Fort Wayne Medical Oncology and Hematology, Hematology Oncology Associates of Central New York, Hematology Oncology Associates of Fredericksburg, Highlands Oncology Group, Jackson Oncology Associates in Mississippi, New York Cancer & Blood Specialists, Oklahoma Cancer Specialists and Research Institute, RCCA-Central Jersey, Southeast Nebraska Cancer Center, Virginia Cancer Institute, and West Cancer Center. Additional research sites are planned over time.
“Clinical trials are critically important to advancing cancer research, but the way trials are run has in many ways not changed in decades, and continues to be burdensome and time-consuming,” said Dr. Lee Schwartzberg, chief medical officer at OneOncology, and physician at West Cancer Center. “The PCG Study has the potential to help transform how clinical trials are conducted, ultimately making research more feasible for all sites and increasing the number of trial opportunities for patients. We hope that the study design and technology deployed in PCG will ultimately become standard practice and used across a wide swath of trials.”
“We’ve been a part of this study since December, and it is an exciting opportunity to be a part of building this research platform. While this study is expected to help patients in the future, it also provides important information for our enrolled patients invaluable to their current management,” shared Dr. Eric Santos, physician at Cancer & Hematology Centers of Western Michigan.
“Using new platforms to accelerate the development and delivery of the best possible medicines for every type of patient is central to our vision for personalized healthcare,” said Mark Lee, global head of personalized healthcare, product development, at Genentech. “The PCG Study represents an important step toward the next iteration of the clinical research ecosystem, opening up opportunities to extend clinical trials into the real world setting to more investigators and more patients than ever before.”
At this year’s ASCO Virtual Scientific Program, Genentech, Flatiron, Foundation Medicine and co-authors will present the study design and objectives in a Trials-In-Progress abstract titled, “A multi-stakeholder platform to prospectively link longitudinal real-world clinico-genomic, imaging, and outcomes data for patients with metastatic lung cancer.”
To learn more about the PCG Study, contact PCG@flatiron.com.
Location:
NEW YORK, NY, May 18, 2020
About Flatiron Health
Flatiron Health is a healthtech company expanding the possibilities for point of care solutions in oncology and using data for good to power smarter care for every person with cancer. Through machine learning and AI, real-world evidence, and breakthroughs in clinical trials, we continue to transform patients’ real-life experiences into knowledge and create a more modern, connected oncology ecosystem. Flatiron Health is an independent affiliate of the Roche Group.
