In recent years, rapid advancement in gene/protein analysis technology has resulted in target molecule identification that may be useful in cancer treatment. Therefore, “Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition” was published in Japan in September 2021. These guidelines were established to align the clinical usefulness of external diagnostic products with the evaluation criteria of the Pharmaceuticals and Medical Devices Agency. The guidelines were scoped for each tumor, and a clinical questionnaire was developed based on a serious clinical problem. This guideline was based on a careful review of the evidence obtained through a literature search, and recommendations were identified following the recommended grades of the Medical Information Network Distribution Services (Minds). Therefore, this guideline can be a tool for cancer treatment in clinical practice. We have already reported the review portion of “Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition” as Part 1. Here, we present the English version of each part of the Clinical Practice Guidelines for Molecular Tumor Marker, Second Edition.

近年来，基因/蛋白质分析技术的快速发展导致了可能有助于癌症治疗的靶分子鉴定。因此，日本于2021年9月发布了《分子肿瘤标志物临床实践指南，第二版》。制定这些指南的目的是为了使外部诊断产品的临床实用性与药品和医疗器械管理局的评估标准保持一致。该指南针对每种肿瘤进行了界定，并根据严重的临床问题制定了临床调查问卷。该指南基于对通过文献检索获得的证据的仔细审查，并根据医疗信息网络分发服务（Minds）的推荐等级确定了建议。因此，该指南可以作为临床实践中癌症治疗的工具。我们已经将《分子肿瘤标志物临床实践指南，第二版》的综述部分报道为第1部分。在此，我们介绍《分子肿瘤标志物临床实践指南，第二版》各部分的英文版。