Article ; Online: A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol.
2024
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 ... ...
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. |
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Language | English |
Publishing date | 2024-04-10 |
Publishing country | England |
Document type | Journal Article |
ZDB-ID | 1409038-7 |
ISSN | 1549-490X ; 1083-7159 |
ISSN (online) | 1549-490X |
ISSN | 1083-7159 |
DOI | 10.1093/oncolo/oyae062 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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