Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols. Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention AgencyLaboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values. Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels. Conclusions RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.

Background: An international reference measurement laboratory network for creatinine (Cr) is lacking; therefore, Korea developed an independent evaluation and certification system. The in vitro diagnostics (IVD) certification program, launched in 2017, formed part of a broader Cr standardization initiative intended to enhance accuracy at the manufacturing stage. Methods: The program was designed to evaluate analytical systems, including all reagent lots, calibrators, and instrument models, twice annually. Bias, imprecision, total error (TE), and linearity were evaluated based on established acceptance criteria. A post-certification process allows submission for a second challenge and validation of corrective actions. Results: Between 2017 and 2023, 489 analytical systems were evaluated. Average acceptance rates for bias, imprecision, TE, and linearity were 70.8%, 95.9%, 87.7%, and 87.8%, respectively. The lowest acceptance rate for bias evaluation was 8.7% for the kinetic Jaffe method without compensation in 2018. Over the 7-year period, the mean absolute percentage bias (absBias%), coefficient of variation (CV), and TE were 4.62%, 1.37%,and 7.29%, respectively. The highest absBias% (7.94%) was observed in the 0.0 ≤ Cr < 1.0target value range. Since 2019, a consistent reduction in absBias% has been observed. Conclusions This program is a pioneering response to the absence of a global certification program for Cr assays. It offers significant advantages, including comprehensive evaluations, fee-free participation, and a robust post-certification process. Continuous participation and improvement efforts by manufacturers have contributed to enhanced accuracy in Cr assays.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Carbon-ion radiotherapy (CIRT) offers superior dose distributions and greater biological effectiveness than conventional photon-based radiotherapy (RT). Due to its higher linear energy transfer and relative biological effectiveness, CIRT is particularly effective against radioresistant tumors and those located near critical organs. Since the first dedicated CIRT facility was established in Japan in 1994, CIRT has demonstrated remarkable efficacy against various malignancies, including head and neck tumors, skull base and upper cervical spine tumors, non-small-cell lung cancer, hepatocellular carcinoma, pancreatic cancer, prostate cancer, and bone and soft tissue sarcomas. This narrative review provides a comprehensive overview of the current status of CIRT, highlighting its clinical indications and future directions. According to clinical studies, CIRT achieves high local control rates with manageable toxicity across multiple cancer types. For instance, in head and neck tumors (e.g., adenoid cystic carcinoma and mucosal melanoma), CIRT has achieved local control rates exceeding 80%. In early-stage non-small-cell lung cancer, CIRT has resulted in local control rates over 90% with minimal toxicity. Moreover, CIRT has shown promise in treating challenging cases of hepatocellular carcinoma and pancreatic cancer, where conventional therapies are limited. Nonetheless, the global adoption of CIRT remains limited due to high costs and complexity. Future directions include conducting randomized controlled trials to establish high-level evidence, integrating new technologies such as ultrahigh-dose-rate (FLASH) therapy, and expanding CIRT facilities globally with strategic planning and cost-effectiveness analyses. If these challenges are addressed, CIRT is poised to play a transformative role in cancer treatment, improving survival rates and the quality of life.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Carbon-ion radiotherapy (CIRT) offers superior dose distributions and greater biological effectiveness than conventional photon-based radiotherapy (RT). Due to its higher linear energy transfer and relative biological effectiveness, CIRT is particularly effective against radioresistant tumors and those located near critical organs. Since the first dedicated CIRT facility was established in Japan in 1994, CIRT has demonstrated remarkable efficacy against various malignancies, including head and neck tumors, skull base and upper cervical spine tumors, non-small-cell lung cancer, hepatocellular carcinoma, pancreatic cancer, prostate cancer, and bone and soft tissue sarcomas. This narrative review provides a comprehensive overview of the current status of CIRT, highlighting its clinical indications and future directions. According to clinical studies, CIRT achieves high local control rates with manageable toxicity across multiple cancer types. For instance, in head and neck tumors (e.g., adenoid cystic carcinoma and mucosal melanoma), CIRT has achieved local control rates exceeding 80%. In early-stage non-small-cell lung cancer, CIRT has resulted in local control rates over 90% with minimal toxicity. Moreover, CIRT has shown promise in treating challenging cases of hepatocellular carcinoma and pancreatic cancer, where conventional therapies are limited. Nonetheless, the global adoption of CIRT remains limited due to high costs and complexity. Future directions include conducting randomized controlled trials to establish high-level evidence, integrating new technologies such as ultrahigh-dose-rate (FLASH) therapy, and expanding CIRT facilities globally with strategic planning and cost-effectiveness analyses. If these challenges are addressed, CIRT is poised to play a transformative role in cancer treatment, improving survival rates and the quality of life.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.

Carbon-ion radiotherapy (CIRT) offers superior dose distributions and greater biological effectiveness than conventional photon-based radiotherapy (RT). Due to its higher linear energy transfer and relative biological effectiveness, CIRT is particularly effective against radioresistant tumors and those located near critical organs. Since the first dedicated CIRT facility was established in Japan in 1994, CIRT has demonstrated remarkable efficacy against various malignancies, including head and neck tumors, skull base and upper cervical spine tumors, non-small-cell lung cancer, hepatocellular carcinoma, pancreatic cancer, prostate cancer, and bone and soft tissue sarcomas. This narrative review provides a comprehensive overview of the current status of CIRT, highlighting its clinical indications and future directions. According to clinical studies, CIRT achieves high local control rates with manageable toxicity across multiple cancer types. For instance, in head and neck tumors (e.g., adenoid cystic carcinoma and mucosal melanoma), CIRT has achieved local control rates exceeding 80%. In early-stage non-small-cell lung cancer, CIRT has resulted in local control rates over 90% with minimal toxicity. Moreover, CIRT has shown promise in treating challenging cases of hepatocellular carcinoma and pancreatic cancer, where conventional therapies are limited. Nonetheless, the global adoption of CIRT remains limited due to high costs and complexity. Future directions include conducting randomized controlled trials to establish high-level evidence, integrating new technologies such as ultrahigh-dose-rate (FLASH) therapy, and expanding CIRT facilities globally with strategic planning and cost-effectiveness analyses. If these challenges are addressed, CIRT is poised to play a transformative role in cancer treatment, improving survival rates and the quality of life.

Background: s/Aims: Reported incidence of extrahepatic bile duct cancer is higher in Asians than in Western populations. Korea, in particular, is one of the countries with the highest incidence rates of extrahepatic bile duct cancer in the world. Although research and innovative therapeutic modalities for extrahepatic bile duct cancer are emerging, clinical guidelines are currently unavailable in Korea. The Korean Society of Hepato-Biliary-Pancreatic Surgery in collaboration with related societies (Korean Pancreatic and Biliary Surgery Society, Korean Society of Abdominal Radiology, Korean Society of Medical Oncology, Korean Society of Radiation Oncology, Korean Society of Pathologists, and Korean Society of Nuclear Medicine) decided to establish clinical guideline for extrahepatic bile duct cancer in June 2021. Methods: Contents of the guidelines were developed through subgroup meetings for each key question and a preliminary draft was finalized through a Clinical Guidelines Committee workshop. Results: In November 2021, the finalized draft was presented for public scrutiny during a formal hearing. Conclusions The extrahepatic guideline committee believed that this guideline could be helpful in the treatment of patients.

Purpose: This report offers a detailed examination of the inception and current state of the Heavy-ion Therapy Center (HITC) at the Yonsei Cancer Center (YCC), setting it apart as the world’s first center equipped with a fixed beam and two superconducting gantries for carbon-ion radiation therapy (CIRT). Materials and Methods: Preparations for CIRT at YCC began in 2013; accordingly, this center has completed a decade of meticulous planning and culminating since the operational commencement of the HITC in April 2023. Results: This report elaborates on the clinical preparation for adopting CIRT in Korea. It includes an extensive description of HITC’s facility layout at YCC, which comprises the accelerator and treatment rooms. Furthermore, this report delineates the clinical workflow, criteria for CIRT application, and the rigorous quality assurance processes implemented at YCC. It highlights YCC’s sophisticated radiation therapy infrastructure, collaborative initiatives, and the efficacious treatment of >200 prostate cancer cases utilizing CIRT. Conclusion This manuscript concludes by discussing the prospective influence of CIRT on the medical domain within Korea, spotlighting YCC’s pioneering contribution and forecasting the widespread integration of this groundbreaking technology.