Liquid Biopsy for Cancer: Current Status and Future Challenges
暫譯: 癌症液體活檢：現狀與未來挑戰

個別腫瘤分子剖析及透過治療相關的選擇壓力追蹤動態演變對臨床腫瘤學至關重要。然而，目前的組織活檢因取樣偏差無法代表腫瘤的空間和時間異質性。

液體活檢是一種替代組織活檢的方法，因為它可以代表來自多個不同病灶的綜合分子特徵，並且在治療過程中透過重複的縱向檢測實現實時追蹤。

本書描述了目前關於前分析問題的知識，包括血液準備的標準化、分析變異性、臨床應用及監管機構批准問題等。關於循環中的目標，重點在於循環腫瘤細胞（CTCs）、循環核酸（ctDNA、游離RNA）、細胞外囊泡、腫瘤教育血小板及其他（蛋白質、代謝物）。

本書將成為腫瘤科醫生豐富的信息和指導來源，並提供對該領域進一步發展的激勵性想法。

翻譯是借助人工智慧完成的，隨後進行了以內容為主的人工修訂。

Dr. Seung-Il Kim is a Professor of Breast Surgery at Yonsei University College of Medicine, Seoul, Republic of Korea. He obtained his M.D. degree from Yonsei University and received his Ph.D. from Korea University College of Medicine. After completing a fellowship at the National Surgical Adjuvant Breast and Bowel Project (NSABP, USA), he has devoted his career to clinical and translational breast cancer research, integrating surgical oncology with liquid biopsy and molecular diagnostics. Dr. Kim has published more than 190 peer-reviewed papers in the fields of surgical oncology and liquid biopsy, including publications in several high-impact journals. His research focuses on leveraging tumor-derived extracellular vesicles (EVs) as platforms for both liquid biopsy and therapeutic innovation, with the goal of advancing precision oncology across the full continuum of cancer management--from molecular diagnosis to targeted therapy. He leads multidisciplinary translational research that unites surgical oncology, molecular biology, bioengineering, and nanomedicine to develop minimally invasive diagnostic strategies, predictive biomarkers, and EV-based therapeutic platforms that enhance precision and predictive medicine in breast cancer. Dr. Kim is also an inventor on several patents related to EV-based cancer diagnostics and microfluidic isolation technologies, reflecting his translational vision that bridges bench and bedside. As a surgeon-scientist committed to interdisciplinary collaboration, he works closely with clinicians, biologists, engineers, and data scientists to transform molecular discoveries into clinically actionable strategies. His ultimate goal is to advance precision and predictive medicine through the clinical implementation of next-generation liquid biopsy and EV-based innovations, improving outcomes for patients with breast cancer and beyond.

Dr. Young Kim is a Postdoctoral Research Fellow at the Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea. He obtained his Ph.D. in Medical Science from Yonsei University under the supervision of Professor Seung-Il Kim, with a dissertation titled "Clinical Significance of Liquid Biopsy through 5-miRNA Signature Profiling in Tumor-derived Extracellular Vesicles to Complement Breast Cancer Diagnosis." His research focuses on high-purity isolation and multi-omics profiling of tumor-derived extracellular vesicles (EVs) for precision oncology and biomarker-driven patient stratification. While pursuing his doctoral training, Dr. Kim accumulated extensive experience in the in vitro diagnostics (IVD) industry, engaging in analytical and clinical validation, quality management, and international regulatory approval. Serving as a Quality Management Representative (QMR) and Regulatory Affairs Specialist, he contributed to the establishment of good manufacturing practice (GMP) systems compliant with ISO 13485:2016 and alignment with global regulatory standards. This industry-based background cultivated his expertise in IVD regulatory science and provided a practical framework for translating innovative biomarkers into clinically applicable diagnostic platforms.

Dr. Kim's work bridges academic discovery and regulatory implementation, integrating industrial insight with scientific rigor. His current research explores the application of liquid biopsy to enable noninvasive, real-time cancer monitoring, emphasizing assay standardization, clinical validity, and translational feasibility. As a scientist positioned at the intersection of molecular oncology, diagnostics, and regulatory science, his long-term goal is to build globally harmonized frameworks that facilitate the clinical adoption of multi-analyte liquid biopsy technologies, ultimately advancing early detection, precision monitoring, and improved outcomes for patients with cancer.

金承一醫生是韓國首爾延世大學醫學院的乳腺外科教授。他在延世大學獲得醫學博士學位，並在高麗大學醫學院獲得博士學位。完成美國國家外科輔助乳腺與腸道計畫（NSABP）的研究員訓練後，他將職業生涯投入於臨床及轉譯乳腺癌研究，將外科腫瘤學與液體活檢及分子診斷相結合。金醫生在外科腫瘤學和液體活檢領域發表了超過190篇經過同行評審的論文，包括在幾本高影響力期刊上的發表。他的研究專注於利用腫瘤衍生的細胞外囊泡（EVs）作為液體活檢和治療創新的平台，目標是推進精準腫瘤學，涵蓋從分子診斷到靶向治療的整個癌症管理過程。他領導的多學科轉譯研究結合了外科腫瘤學、分子生物學、生物工程和納米醫學，開發微創診斷策略、預測生物標記和基於EV的治療平台，以增強乳腺癌的精準醫療和預測醫學。金醫生還是幾項與基於EV的癌症診斷和微流體分離技術相關的專利發明人，反映了他將基礎研究與臨床應用相結合的轉譯願景。作為一名致力於跨學科合作的外科醫生科學家，他與臨床醫生、生物學家、工程師和數據科學家密切合作，將分子發現轉化為可臨床應用的策略。他的最終目標是通過臨床實施下一代液體活檢和基於EV的創新，推進精準和預測醫學，改善乳腺癌患者及其他患者的治療結果。

金揚醫生是韓國首爾延世大學醫學院外科系的博士後研究員。他在延世大學獲得醫學科學博士學位，指導教授為金承一教授，論文題目為「透過腫瘤衍生細胞外囊泡的5-miRNA特徵分析，液體活檢的臨床意義以補充乳腺癌診斷」。他的研究專注於腫瘤衍生細胞外囊泡（EVs）的高純度分離和多組學分析，以實現精準腫瘤學和生物標記驅動的患者分層。在攻讀博士學位期間，金醫生在體外診斷（IVD）行業積累了豐富的經驗，參與分析和臨床驗證、質量管理和國際法規批准。作為質量管理代表（QMR）和法規事務專家，他為建立符合ISO 13485:2016的良好製造規範（GMP）系統及與全球法規標準的對齊做出了貢獻。這一行業背景培養了他在IVD法規科學方面的專業知識，並為將創新生物標記轉化為臨床可應用的診斷平台提供了實用框架。

金醫生的工作橋接了學術發現和法規實施，將產業洞察與科學嚴謹性相結合。他目前的研究探索液體活檢的應用，以實現非侵入性、實時的癌症監測，強調檢測標準化、臨床有效性和轉譯可行性。作為一名位於分子腫瘤學、診斷和法規科學交匯處的科學家，他的長期目標是建立全球協調的框架，以促進多分析物液體活檢技術的臨床採用，最終推進早期檢測、精準監測和改善癌症患者的治療結果。