Lustberg, Maryam
Wu, Xuan
Fernández-Martínez, Juan Luis
de Andrés-Galiana, Enrique J.
Philips, Santosh
Leibowitz, Jeffrey
Schneider, Bryan
Sonis, Stephen
Funding for this research was provided by:
Division of Cancer Prevention, National Cancer Institute (RO1CA238946-02, RO1CA238946-02, RO1CA238946-02, RO1CA238946-02, RO1CA238946-02, RO1CA238946-02, RO1CA238946-02, RO1CA238946-02)
Article History
Received: 12 August 2022
Accepted: 16 January 2023
First Online: 28 January 2023
Declarations
:
: This is a secondary analysis of a completed clinical trial ECOG 5103. ECOG-ACRIN E5103 was previously approved, including additional secondary analyses of genomic data, by the Central Institutional Review Board (CIRB) for the National Cancer Institute (NCI) and conducted in accordance with Good Clinical Practice guidelines as defined by the International Conference on Harmonisation. All patients provided IRB-approved written informed consent. This study was monitored by the ECOG-ACRIN Data Safety Monitoring Committee and the NCI. The current secondary analysis has been approved by the ECOG Executive Board. The National Cancer Institute Central Institutional Review Board (IRB) approved the protocol the IRB of record for a subset of institutions; the remaining sites used their own individual IRBs. Written informed consent was obtained from all participants. Secondary analyses were in accordance with original consent and IRB approval and were further approved by the ECOG Executive Board.
: Dr. Sonis reports personal fees from Biomodels, LLC, and personal fees from Primary Endpoint Solutions, LLC, outside of the submitted work. As an employee of Biomodels and PES, he is involved in assisting industry, government, and academics in the study and enablement of drugs, biologicals, and devices to treat patients for a broad range of indications including cancer and toxicities of cancer therapy. He does not have equity or receive payment from any of the companies’ clients. The other authors have no relevant disclosers.