The Japanese Society of Pathology Practical Guidelines on the handling of pathological tissue samples for cancer genomic medicine

  • Yutaka Hatanaka
    Research Division of Genome Companion Diagnostics Hokkaido University Hospital Hokkaido Japan
  • Takeshi Kuwata
    Department of Genetic Medicine and Services National Cancer Center Hospital East Chiba Japan
  • Eiichi Morii
    Department of Pathology Osaka University Graduate School of Medicine Osaka Japan
  • Yae Kanai
    Department of Pathology Keio University School of Medicine Tokyo Japan
  • Hitoshi Ichikawa
    Department of Clinical Genomics National Cancer Center Research Institute Tokyo Japan
  • Takashi Kubo
    Department of Clinical Genomics National Cancer Center Research Institute Tokyo Japan
  • Kanako C. Hatanaka
    Center for Development of Advanced Diagnostics Hokkaido University Hospital Hokkaido Japan
  • Kazuko Sakai
    Department of Genome Biology Kindai University Faculty of Medicine Osaka Japan
  • Kazuto Nishio
    Department of Genome Biology Kindai University Faculty of Medicine Osaka Japan
  • Satoshi Fujii
    Exploratory Oncology Research & Clinical Trial Center National Cancer Center Chiba Japan
  • Wataru Okamoto
    Translational Research Support Section National Cancer Center Hospital East Chiba Japan
  • Takayuki Yoshino
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Chiba Japan
  • Atsushi Ochiai
    Exploratory Oncology Research & Clinical Trial Center National Cancer Center Chiba Japan
  • Yoshinao Oda
    Department of Anatomic Pathology, Pathological Sciences, Graduate School of Medical Sciences Kyushu University Fukuoka Japan

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<jats:title>Abstract</jats:title><jats:p>Clinical cancer genomic testing based on next‐generation sequencing can help select genotype‐matched therapy and provide diagnostic and prognostic information. Pathological tissue from malignant tumors obtained during routine practice are frequently used for genomic testing. This article is aimed to standardize the proper handling of pathological specimens in practice for genomic medicine based on the findings established in “Guidelines on the handling of pathological tissue samples for genomic medicine (in Japanese)” published by The Japanese Society of Pathology (JSP) in 2018. The two‐part practical guidelines are based on empirical data analyses; Part 1 describes the standard preanalytic operating procedures for tissue collection, processing, and storage of formalin‐fixed paraffin‐embedded (FFPE) samples, while Part 2 describes the assessment and selection of FFPE samples appropriate for genomic testing, typically conducted by a pathologist. The guidelines recommend that FFPE sample blocks be used within 3 years from preparation, and the tumor content should be ≥30% (minimum 20%). The empirical data were obtained from clinical studies performed by the JSP in collaboration with leading Japanese cancer genome research projects. The Japanese Ministry of Health, Labour, and Welfare (MHLW) recommended to comply with the JSP practical guidelines in implementing cancer genomic testing under the national health insurance system in over 200 MHLW‐designated core and cooperative cancer genome medicine hospitals in Japan.</jats:p>

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