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Trial Tests Liquid Biopsy Feasibility in Lung Cancer

Blood sample tubes


18 May 2020. Companies that offer biotechnology, diagnostics, and analytics are testing liquid biopsies to make personalized diagnosis and care feasible for lung cancer patients. The study called the Prospective Clinico-Genomic, or PCG, study is an initiative of Flatiron Health, Foundation Medicine, and Genentech, all part of the Roche group of companies.

The PCG study first formed in December 2019, an outgrowth of continuing work by the companies to streamline clinical care for lung cancer patients, including clinical trial participation, by making more use of the vast amounts of real-world data produced and analyzed by modern genomics. Genentech, an early biotechnology company and a Roche subsidiary in South San Francisco, is sponsoring the PCG study, described in a poster session later this month at the virtual scientific meeting of American Society of Clinical Oncology.

The study is a clinical trial enrolling 1,000 patients with metastatic, or spreading, lung cancer, both non-small cell lung cancer, the most common variety, and extensive-stage small cell lung cancer, who undergo standard treatments for limiting development or spread of their tumors. Participants are recruited from 20 sites, community and academic medical centers affiliated with Flatiron Health’s data network. Flatiron Health, in New York, captures and normalizes data from electronic health records of cancer patients at hundreds of affiliated medical centers, and provides analytics of those data for health care providers, insurance companies, and life science researchers.

Participants will be asked to provide blood samples at three points during their care: at enrollment in the study, first tumor assessment, and as the disease progresses or at the end of their therapy. The blood samples will then be analyzed by Foundation Medicine, in Cambridge, Massachusetts that provides personalized assessments of circulating tumor cells in the blood from the patients’ tumors, so-called liquid biopsies. The main goal of the project is to assess genomic changes in patients’ tumors over the course of their treatment, which in many cases today require lung tissue specimens taken with invasive surgical biopsies.

The researchers also plan to conduct deeper analytics of genomic data from participants, combined with images and electronic health record data, building a comprehensive data platform for gaining more insights into patients’ conditions and eventually return personalized treatment plans. This more comprehensive platform, says the study team, aims also to put less demand on patients for data collection, as well as fewer surgical biopsies, thus easing lung cancer patients’ treatments as well as participation in clinical trials.

“Through technology-driven innovation,” says Bobby Green, chief medical officer at Flatiron Health in a company statement, “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.”

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