A process to reanalyze clinical DNA sequencing data for biomarker matching in the Lung-MAP Master Protocol.

Authors

Joel W Neal
Katherine Minichiello
Ryan Brennick
Richard S P Huang
Matthew C Hiemenz
Cornel Amler
Jyoti Patel
Roy Herbst
Karen L Reckamp
Hossein Borghaei
Louise Highleyman
Mary W Redman
Lincoln W Pasquina
David E Kozono

Publication Date

6-3-2024

Journal

The Oncologist

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.

Keywords

Humans, Lung Neoplasms, Biomarkers, Tumor, Sequence Analysis, DNA, Genomics

Comments

PMID: 38597608