A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol
Year: 2024
Type: article
Abstract: For cancer clinical trials that require central confirmation of tumor genomic profiling, exhaustion of tissue from standard-of-care testing may prevent enrollment. For Lung-MAP, a master protocol that requires results from a defined centralized clinical trial assay to assign patients to a therapeutic substudy, we developed a process to repurpose existing commercial vendor raw genomic data for eligibility: genomic data reanalysis (GDR). Molecular results for substudy assignment were successfully generated for 369 of the first 374 patients (98.7%) using GDR for Lung-MAP, with a median time from request to result of 9 days. During the same period, 691 of 791 (87.4%) tissue samples received successfully yielded results, in a median of 14 days beyond sample acquisition. GDR is a scalable bioinformatic pipeline that expedites reanalysis of existing data for clinical trials in which validated integral biomarker testing is required for participation.
Source: The Oncologist
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $4,045
Funders: American Association for Cancer Research, Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Gilead Sciences, University of Pennsylvania, Regeneron Pharmaceuticals, Exelixis, Society for Immunotherapy of Cancer, Novocure, Mirati Therapeutics, BeiGene, Incyte, Natera, Springworks Therapeutics, PharmaMar, National Institutes of Health, Genentech, EMD Serono, Loxo Oncology, Foundation Medicine, National Cancer Institute, National Center for Advancing Translational Sciences, Daiichi Sankyo Europe
OpenAlex ID: W4394675161