Document is current

Article History

Accepted: 7 May 2022

First Online: 13 June 2022

Declarations

:

: RareCyte, Inc.

: LCK, SK, JL, and ZC have no conflicts of interest to report. ABR, EL, YS, LU, EPK are employees of RareCyte, Inc. LQMC has no direct conflicts of interests but has received minor <i>de minimus</i> personal advisory board consulting fees and prior institutional research grant funding from Merck, Pfizer, Dynavax and Novartis, Astra-Zeneca in the last three years, de minimus advisory board consulting fees and current institutional research grant funding from Alkermes. She reports current institutional grant funding only from Oncorus. She reports minor de minimus consulting/advisory board fees from Cullinan and Elicio, Gilead, Regeneron, Sanofi-Genzyme and Daiichi Sankyo, Ipsen, Nanobiotix, Beigene, Jazz Pharmaceuticals. Research grant funding only provided to her prior institution from Bristol Myers Squibb, Genentech, Seattle Genetics, Lily/Imclone. Over the last 3 years (all unrelated to this study). PG has received consulting fees from AstraZeneca, Astellas Pharma, Bayer, Bristol Myers Squibb, Dyania Health, EMD Serono, Exelixis, Foundation Medicine, Genentech/Roche, Genzyme, GlaxoSmithKline, Guardant Health, Gilead Sciences, Infinity Pharmaceuticals, Janssen, Lucence Health, Merck, Mirati Therapeutics, Pfizer, QED Therapeutics, Regeneron Pharmaceuticals, Seattle Genetics, Silverback Therapeutics, UroGen, 4D Pharma PLC. His institution has received grants from Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm, EMD Serono, G1 Therapeutics, Gilead Sciences, GlaxoSmithKline, Merck, Mirati Therapeutics, Pfizer, QED Therapeutics. VKG has no direct conflicts of interests with this work but has equity in SEngine Precision Medicine, Novilla, and 3rdEyeBio. VKG is on the scientific boards for Puma Biotechnology, New Equilibrium Biosciences, Phoenix Molecular Designs; he is also on speakers’ bureaus for Puma Biotechnology, Genentech/Roche, Hologics; and receives research support to his institution from Agendia.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the IRB Committee the Fred Hutchinson Cancer Research Center Cancer Consortium (#10031).

: Patients agreed to participate in this study under informed consent as approved by the Fred Hutchinson Cancer Center Cancer Consortium IRB.

: As part of informed consent for this study, patients agreed to allow the publication of deidentified results.

: Deidentified patient data is shared in aggregate within the paper supplement.

: N/A.

: LCK wrote the protocol, consented patients, processed patient samples, performed CTC analysis, performed data analysis, and wrote the manuscript. JL performed biostatistical analysis and wrote the manuscript. SK processed patient samples and performed CTC analysis. ABR performed CTC analysis and wrote the manuscript. EL developed the tissue staining protocol and performed tissue staining and analysis. LU performed CTC analysis. YS contributed to assay development. JL and ZC performed biostatistical analysis and wrote the manuscript. LQC and PG recruited and consented patients and wrote the manuscript. EPK performed tissue staining analysis and wrote the manuscript. VG recruited and consented patients, performed data analysis, and wrote the manuscript.