Expert panel consensus recommendations on the use of circulating tumor <scp>DNA</scp> assays for patients with advanced solid tumors

  • Mitsuho Imai
    Translational Research Support Section National Cancer Center Hospital East Kashiwa Japan
  • Yoshiaki Nakamura
    Translational Research Support Section National Cancer Center Hospital East Kashiwa Japan
  • Kuniko Sunami
    Department of Laboratory Medicine National Cancer Center Hospital Tokyo Japan
  • Hidenori Kage
    Department of Next‐Generation Precision Medicine Development Laboratory Graduate School of Medicine The University of Tokyo Tokyo Japan
  • Keigo Komine
    Department of Medical Oncology Tohoku University Hospital Sendai Japan
  • Takafumi Koyama
    Department of Experimental Therapeutics National Cancer Center Hospital Tokyo Japan
  • Toraji Amano
    Clinical Research and Medical Innovation Center Hokkaido University Hospital Hokkaido Japan
  • Daisuke Ennishi
    Center for Comprehensive Genomic Medicine Okayama University Hospital Okayama Japan
  • Masashi Kanai
    Department of Therapeutic Oncology Graduate School of Medicine Kyoto University Kyoto Japan
  • Hirotsugu Kenmotsu
    Division of Thoracic Oncology Shizuoka Cancer Center Suntougun Japan
  • Takahiro Maeda
    Division of Precision Medicine Kyushu University Graduate School of Medical Sciences Fukuoka Japan
  • Sachi Morita
    Department of Clinical Oncology and Chemotherapy Nagoya University Hospital Nagoya Japan
  • Daisuke Sakai
    Center for Cancer Genomics and Personalized Medicine Osaka University Hospital Suita Japan
  • Hideaki Bando
    Translational Research Support Section National Cancer Center Hospital East Kashiwa Japan
  • Akitaka Makiyama
    Cancer Center Gifu University Hospital Gifu Japan
  • Tatsuya Suzuki
    Department of Hematology National Cancer Center Hospital Tokyo Japan
  • Makoto Hirata
    Department of Genetic Medicine and Services National Cancer Center Hospital Tokyo Japan
  • Shinji Kohsaka
    Division of Cellular Signaling National Cancer Center Research Institute Tokyo Japan
  • Katsuya Tsuchihara
    Division of Translational Informatics Exploratory Oncology Research and Clinical Trial Center National Cancer Center Kashiwa Japan
  • Yoichi Naito
    Department of General Internal Medicine/Experimental Therapeutics/Medical Oncology National Cancer Center Hospital East Kashiwa Japan
  • Takayuki Yoshino
    Translational Research Support Section National Cancer Center Hospital East Kashiwa Japan

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<jats:title>Abstract</jats:title><jats:p>Comprehensive genomic profiling is increasingly used to facilitate precision oncology based on molecular stratification. In addition to conventional tissue comprehensive genomic profiling, comprehensive genomic profiling of circulating tumor DNA has become widely utilized in cancer care owing on its advantages, including less invasiveness, rapid turnaround time, and capturing heterogeneity. However, circulating tumor DNA comprehensive genomic profiling has some limitations, mainly false negatives due to low levels of plasma circulating tumor deoxyribonucleic acid and false positives caused by clonal hematopoiesis. Nevertheless, no guidelines and recommendations fully address these issues. Here, an expert panel committee involving representatives from 12 Designated Core Hospitals for Cancer Genomic Medicine in Japan was organized to develop expert consensus recommendations for the use of circulating tumor deoxyribonucleic acid‐based comprehensive genomic profiling. The aim was to generate guidelines for clinicians and allied healthcare professionals on the optimal use of the circulating tumor DNA assays in advanced solid tumors and to aid the design of future clinical trials that utilize and develop circulating tumor DNA assays to refine precision oncology. Fourteen clinical questions regarding circulating tumor deoxyribonucleic acid comprehensive genomic profiling including the timing of testing and considerations for interpreting results were established by searching and curating associated literatures, and corresponding recommendations were prepared based on the literature for each clinical question. Final consensus recommendations were developed by voting to determine the level of each recommendation by the Committee members.</jats:p>

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