Cell-Free DNA Analysis With Clinicopathologic Factors for Early Detection and Refining Lymph Node Metastasis Risk in T1 Colorectal Cancer: Results From the COSMOS-CRC Study.

Tatsuro Murano¹, Hiroaki Ikematsu¹, Nobuhisa Matsuhashi², Yuichiro Tsukada³, Manabu Shiozawa⁴, Takeshi Kato⁵, Eiji Oki⁶, Toshifumi Yamaguchi⁷, Yoshinori Kagawa⁸, Akiyoshi Kanazawa⁹, Takashi Ohta¹⁰, Akira Ouchi¹¹, Hiroshi Uchigata¹², Chiemi Notake¹², Elmira Forouzmand¹³, Yupeng He¹³, Victoria M Raymond¹³, Sven Duenwald¹³, Hideaki Bando¹⁴, Takayuki Yoshino¹⁴, Yoshiaki Nakamura¹⁴

¹Department of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.

²Department of Gastroenterological Surgery and Pediatric Surgery, Gifu University Graduate School of Medicine, Gifu, Japan.

³Department of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.

⁴Department of Gastroenterological Surgery, Kanagawa Cancer Center, Kanagawa, Japan.

⁵Department of Surgery, NHO Osaka National Hospital, Osaka, Japan.

⁶Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University Hospital, Fukuoka, Japan.

⁷Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Osaka, Japan.

⁸Department of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan.

⁹Department of Surgery, Shimane Prefectural Central Hospital, Shimane, Japan.

¹⁰Department of Clinical Oncology, Kansai Rosai Hospital, Hyogo, Japan.

¹¹Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Aichi, Japan.

¹²Translational Research Support Office, National Cancer Center Hospital East, Chiba, Japan.

¹³Guardant Health Inc, Redwood City, CA.

¹⁴Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

PubMed PMC DOI PDF

Abstract

PURPOSE: The Shield test is a blood-based assay that uses multimodal analysis of cell-free DNA (cfDNA) to enable noninvasive colorectal cancer (CRC) detection. The aim of this study was to assess the diagnostic performance of the cfDNA test for CRC and advanced precancerous lesions (APLs) and evaluate its potential clinical utility, particularly in early-stage disease. METHODS: In this prospectiv…

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