Document is current

Article History

Received: 21 November 2025

Accepted: 21 February 2026

First Online: 6 March 2026

Declarations

:

: The authors declare no direct conflicts of interest relevant to this work. As the analysis incorporates data generated within the framework of the MONSTAR-SCREEN-3 study and ToMMo cohort, potential indirect associations arising from that context cannot be fully excluded. Here is that list: Shibuki T. reports honoraria from AstraZeneca and Novartis. Hashimoto T. reports honoraria from CytoGen and Takata Pharmaceutical. Fujisawa T. reports honoraria from Amelieff, AstraZeneca, and MSD outside the submitted work. Imai M. reports personal fees from Caris Life Sciences, Guardant Health, Inc., and Sumitomo Corp outside the submitted work. Misumi T. reports honoraria from Chugai and AstraZeneca. Junichiro Yuda: research funding from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, BrighPath Bio, Celaid Therapeutics, Chugai, Daiichi Sankyo, Genmab, Incyte, Janssen Pharmaceutical, Mitsubishi Tanabe, MSD, Novartis, Sanofi, Sumitomo Pharma and Takeda Pharmaceutical. Nakamura N. reports personal fees from Guardant Health Pte, Ltd., Natera, Inc., Roche, Ltd., Premo Partners, Inc., Takeda Pharmaceutical, Exact Sciences Corporation, Gilead Sciences, Inc., MSD, Eisai Co., Ltd., Zeria Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., CareNet, Inc., Hisamitsu Pharmaceutical Co., Inc., Taiho Pharmaceutical Co., Ltd., Becton, Dickinson and Company, and Guardant Health Japan Corp.; grants and personal fees from Seagen, Inc., Daiichi Sankyo Co., Ltd., and Chugai Pharmaceutical Co., Ltd.; as well as grants from Genomedia Inc., Guardant Health AMEA, Inc., Guardant Health, Inc., Tempus Labs, Inc., and Roche Diagnostics K.K. outside the submitted work. Bando H. reports personal fees from Ono Pharmaceutical, Taiho Pharmaceutical, and Eli Lilly Japan K. K. outside the submitted work. Yoshino T. reports personal fees from Chugai Pharmaceutical Co. Ltd., Takeda Pharmaceutical, Merck Biopharma Co. Ltd., Bayer Yakuhin, Ono Pharmaceutical, MSD, and Sumitomo Corp, as well as grants from Amgen, Chugai Pharmaceutical, Daiichi Sankyo, Eisai Co. Ltd., FALCO Biosystems, Genomedia, Molecular Health, MSD, Nippon Boehringer Ingelheim Co., Ltd., Ono Pharmaceutical, Pfizer, Roche Diagnostics, Sanofi, Sysmex, and Taiho Pharmaceutical outside the submitted work. The other authors have no competing interests to declare.

: The research protocol was reviewed and approved by the Institutional Review Boards of the National Cancer Center Hospital East and ToMMo (approval number: 2023–349). All procedures were carried out in accordance with the principles of the Declaration of Helsinki and with Japan’s Ethical Guidelines for Medical and Health Research Involving Human Subjects. Prospective participants who provided blood samples for ctDNA analysis gave written informed consent prior to enrollment. For studies using archived data, the Institutional Review Boards granted a waiver of informed consent in accordance with national regulations.

: Written informed consent, including consent for publication, was obtained from participants who provided new biospecimens prospectively. For participants whose existing data and samples were used retrospectively, consent was waived under an opt-out process approved by the institutional review boards. All data will be presented in a manner that precludes individual identification.