Abstract
TPS2087 Background: Making personalized diagnostics and treatments a reality for every cancer patient necessitates comprehensively capturing the patient journey. Real-world data has shown promise for the future of clinical research and advancing precision medicine. However, certain limitations exist such as data quality management as well as bias and confounding factors associated with retrospective analyses. We present a multi-stakeholder platform to prospectively collect and link real-world clinico-genomic, imaging, and outcomes data to longitudinal blood genomic profiling for lung cancer. Methods: This study is enrolling approximately 1000 patients with metastatic non-small cell lung cancer or extensive-stage small cell lung cancer who will initiate standard-of-care systemic anti-neoplastic treatment, regardless of line of therapy, at 20 community oncology and academic practices within the Flatiron Health network. Relevant clinical data points from both structured and unstructured fields will be collected through the electronic health records via technology-enabled abstraction, eliminating the need for case report forms. Digital pathology and clinical images at standard-of-care visits will be collected. Blood samples for circulating tumor DNA (ctDNA) profiling using FoundationOne Liquid will be collected at three timepoints: enrollment, first tumor assessment, and end of treatment. Tumor tissue samples may be submitted at baseline for genomic profiling using FoundationOne CDx. Overall survival follow-up will occur until death, withdrawal of consent, loss to follow-up, or end of study. The objectives are to evaluate 1) the feasibility of building a scalable, prospective platform and 2) the associations between ctDNA and real-world clinical outcomes, including overall survival. Enrollment is ongoing. Clinical trial information: NCT04180176.
Published Version
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