1.Feasibility of Circulating Tumor DNA Detection in the Cerebrospinal Fluid of Patients With Central Nervous System Involvement in Large B-Cell Lymphoma
Seok Jin KIM ; Jin Ju KIM ; Mi Ri PARK ; Bon PARK ; Kyung Ju RYU ; Sang Eun YOON ; Won Seog KIM ; Saeam SHIN ; Seung-Tae LEE
Annals of Laboratory Medicine 2025;45(1):90-95
We explored the utility of cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) sequencing as a noninvasive diagnostic tool for detecting central nervous system (CNS) involvement in patients with diffuse large B-cell lymphoma (DLBCL). Secondary CNS involvement in DLBCL, although rare (~5% of cases), presents diagnostic and prognostic challenges during systemic disease progression or relapse. Effective treatment is impeded by the blood–brain barrier. This was a prospective cohort study (Samsung Lymphoma Cohort Study III) involving 17 patients with confirmed CNS involvement. High-throughput sequencing was conducted using targeted gene panels designed to detect low-frequency variants and copy number alterations pertinent to lymphomas in ctDNA extracted from archived CSF samples. Despite challenges such as low DNA concentrations affecting library construction, the overall variant detection rate was 76%. Detected variants included those in genes commonly implicated in CNS lymphoma, such as MYD88. The study highlights the potential of CSF ctDNA sequencing to identify CNS involvement in DLBCL, providing a promising alternative to more invasive diagnostic methods such as brain biopsy, which are not always feasible. Further validation is necessary to establish the clinical utility of this method, which could significantly enhance the management and outcomes of DLBCL patients with suspected CNS involvement.
2.Prognostic Value of Residual Circulating Tumor DNA in Metastatic Pancreatic Ductal Adenocarcinoma
Hongkyung KIM ; Jinho LEE ; Mi Ri PARK ; Zisun CHOI ; Seung Jung HAN ; Dongha KIM ; Saeam SHIN ; Seung-Tae LEE ; Jong Rak CHOI ; Seung Woo PARK
Annals of Laboratory Medicine 2025;45(2):199-208
Background:
Circulating tumor DNA (ctDNA) is a potential biomarker in pancreatic ductal adenocarcinoma (PDAC). However, studies on residual ctDNA in patients post-chemotherapy are limited. We assessed the prognostic value of residual ctDNA in metastatic PDAC relative to that of carbohydrate antigen 19-9 (CA19-9).
Methods:
ctDNA analysis using a targeted next-generation sequencing panel was performed at baseline and during chemotherapy response evaluation in 53 patients. Progression-free survival (PFS) and overall survival (OS) were first evaluated based on ctDNA positivity at baseline. For further comparison, patients testing ctDNA-positive at baseline were subdivided based on residual ctDNA into ctDNA responders (no residual ctDNA post-chemotherapy) and ctDNA non-responders (residual ctDNA post-chemotherapy). Additional survival analysis was performed based on CA19-9 levels.
Results:
The baseline ctDNA detection rate was 56.6%. Although clinical outcomes tended to be poorer in patients with baseline ctDNA positivity than in those without, the differences were not significant. Residual ctDNA post-chemotherapy was associated with reduced PFS and OS. The prognosis of ctDNA responders was better than that of non-responders but did not significantly differ from that of ctDNA-negative individuals (no ctDNA both at baseline and during post-chemotherapy). Compared with ctDNA responses to che-motherapy, a ≥ 50% decrease in the CA19-9 level had less effect on both PFS and OSbased on hazard ratios and significance levels. ctDNA could be monitored in half of the patients whose baseline CA19-9 levels were within the reference range.
Conclusions
Residual ctDNA analysis post-chemotherapy is a promising approach for predicting the clinical outcomes of patients with metastatic PDAC.
3.Changes in the Infection Control Organization of General Hospitals and the Work of Infection Control Nurses during the COVID-19Pandemic in South Korea
Ri Hye PARK ; Jae Sim JEONG ; Eun Suk PARK ; A Reum KIM ; Yoon Jung KIM ; Hye Ran CHOI ; Mi Na KIM
Korean Journal of healthcare-associated Infection Control and Prevention 2024;29(2):116-127
Background:
This study investigates changes in infection control organizations and the roles of infection control nurses in healthcare institutions during the prolonged COVID-19 pandemic. It aims to provide evidence for preparing effective responses to future emerging infectious diseases.
Methods:
A survey was conducted from August 9 to 27, 2021, targeting infection control nurses working in infection control departments of general hospitals in South Korea with more than 100 beds.
Results:
A total of 118 (38.3%) healthcare institutions responded, and 113 questionnaires ultimately analyzed. Changes in infection control organizations observed during the COVID-19 pandemic included alterations in infection control department staffing (34.5%), work arrangements (92.0%), IT systems development (45.1%), facilities and equipment (92.9%), and systems for responding to emerging infectious diseases (99.1%). Over 50% of infection control tasks were performed either frequently or daily during the pandemic, with the most significant workload increase observed in epidemiological investigations (77.9%). The most challenging task for infection control nurses was establishing and operating epidemic management systems (82.3%). Among personal factors hindering their work, a sense of responsibility for their duties scored the highest (mean 4.73/5 points). The primary structural and environmental barrier was insufficient staffing (mean 4.36/5 points). The most critical need for improving infection control efforts was increased staffing in infection control departments and enhanced administrative support (mean 4.63/5 points).
Conclusion
The COVID-19 pandemic brought significant changes to infection control organizations and the roles of infection control nurses. Based on the lessons learned, healthcare institutions must systematically restructure infection control organizations and enhance the expertise of infection control nurses to respond effectively to future outbreaks of emerging infectious diseases.
4.Changes in the Infection Control Organization of General Hospitals and the Work of Infection Control Nurses during the COVID-19Pandemic in South Korea
Ri Hye PARK ; Jae Sim JEONG ; Eun Suk PARK ; A Reum KIM ; Yoon Jung KIM ; Hye Ran CHOI ; Mi Na KIM
Korean Journal of healthcare-associated Infection Control and Prevention 2024;29(2):116-127
Background:
This study investigates changes in infection control organizations and the roles of infection control nurses in healthcare institutions during the prolonged COVID-19 pandemic. It aims to provide evidence for preparing effective responses to future emerging infectious diseases.
Methods:
A survey was conducted from August 9 to 27, 2021, targeting infection control nurses working in infection control departments of general hospitals in South Korea with more than 100 beds.
Results:
A total of 118 (38.3%) healthcare institutions responded, and 113 questionnaires ultimately analyzed. Changes in infection control organizations observed during the COVID-19 pandemic included alterations in infection control department staffing (34.5%), work arrangements (92.0%), IT systems development (45.1%), facilities and equipment (92.9%), and systems for responding to emerging infectious diseases (99.1%). Over 50% of infection control tasks were performed either frequently or daily during the pandemic, with the most significant workload increase observed in epidemiological investigations (77.9%). The most challenging task for infection control nurses was establishing and operating epidemic management systems (82.3%). Among personal factors hindering their work, a sense of responsibility for their duties scored the highest (mean 4.73/5 points). The primary structural and environmental barrier was insufficient staffing (mean 4.36/5 points). The most critical need for improving infection control efforts was increased staffing in infection control departments and enhanced administrative support (mean 4.63/5 points).
Conclusion
The COVID-19 pandemic brought significant changes to infection control organizations and the roles of infection control nurses. Based on the lessons learned, healthcare institutions must systematically restructure infection control organizations and enhance the expertise of infection control nurses to respond effectively to future outbreaks of emerging infectious diseases.
5.Changes in the Infection Control Organization of General Hospitals and the Work of Infection Control Nurses during the COVID-19Pandemic in South Korea
Ri Hye PARK ; Jae Sim JEONG ; Eun Suk PARK ; A Reum KIM ; Yoon Jung KIM ; Hye Ran CHOI ; Mi Na KIM
Korean Journal of healthcare-associated Infection Control and Prevention 2024;29(2):116-127
Background:
This study investigates changes in infection control organizations and the roles of infection control nurses in healthcare institutions during the prolonged COVID-19 pandemic. It aims to provide evidence for preparing effective responses to future emerging infectious diseases.
Methods:
A survey was conducted from August 9 to 27, 2021, targeting infection control nurses working in infection control departments of general hospitals in South Korea with more than 100 beds.
Results:
A total of 118 (38.3%) healthcare institutions responded, and 113 questionnaires ultimately analyzed. Changes in infection control organizations observed during the COVID-19 pandemic included alterations in infection control department staffing (34.5%), work arrangements (92.0%), IT systems development (45.1%), facilities and equipment (92.9%), and systems for responding to emerging infectious diseases (99.1%). Over 50% of infection control tasks were performed either frequently or daily during the pandemic, with the most significant workload increase observed in epidemiological investigations (77.9%). The most challenging task for infection control nurses was establishing and operating epidemic management systems (82.3%). Among personal factors hindering their work, a sense of responsibility for their duties scored the highest (mean 4.73/5 points). The primary structural and environmental barrier was insufficient staffing (mean 4.36/5 points). The most critical need for improving infection control efforts was increased staffing in infection control departments and enhanced administrative support (mean 4.63/5 points).
Conclusion
The COVID-19 pandemic brought significant changes to infection control organizations and the roles of infection control nurses. Based on the lessons learned, healthcare institutions must systematically restructure infection control organizations and enhance the expertise of infection control nurses to respond effectively to future outbreaks of emerging infectious diseases.
6.Changes in the Infection Control Organization of General Hospitals and the Work of Infection Control Nurses during the COVID-19Pandemic in South Korea
Ri Hye PARK ; Jae Sim JEONG ; Eun Suk PARK ; A Reum KIM ; Yoon Jung KIM ; Hye Ran CHOI ; Mi Na KIM
Korean Journal of healthcare-associated Infection Control and Prevention 2024;29(2):116-127
Background:
This study investigates changes in infection control organizations and the roles of infection control nurses in healthcare institutions during the prolonged COVID-19 pandemic. It aims to provide evidence for preparing effective responses to future emerging infectious diseases.
Methods:
A survey was conducted from August 9 to 27, 2021, targeting infection control nurses working in infection control departments of general hospitals in South Korea with more than 100 beds.
Results:
A total of 118 (38.3%) healthcare institutions responded, and 113 questionnaires ultimately analyzed. Changes in infection control organizations observed during the COVID-19 pandemic included alterations in infection control department staffing (34.5%), work arrangements (92.0%), IT systems development (45.1%), facilities and equipment (92.9%), and systems for responding to emerging infectious diseases (99.1%). Over 50% of infection control tasks were performed either frequently or daily during the pandemic, with the most significant workload increase observed in epidemiological investigations (77.9%). The most challenging task for infection control nurses was establishing and operating epidemic management systems (82.3%). Among personal factors hindering their work, a sense of responsibility for their duties scored the highest (mean 4.73/5 points). The primary structural and environmental barrier was insufficient staffing (mean 4.36/5 points). The most critical need for improving infection control efforts was increased staffing in infection control departments and enhanced administrative support (mean 4.63/5 points).
Conclusion
The COVID-19 pandemic brought significant changes to infection control organizations and the roles of infection control nurses. Based on the lessons learned, healthcare institutions must systematically restructure infection control organizations and enhance the expertise of infection control nurses to respond effectively to future outbreaks of emerging infectious diseases.
7.Fed and fasted bioequivalence assessment of two formulations of extended-release fixed-dose combination dapagliflozin/metformin (10/1,000 mg) tablets in healthy subjects
Hae Won LEE ; Woo Youl KANG ; Ji Seo PARK ; Jae Hwa LEE ; Mi-Ri GWON ; Dong Heon YANG ; Eun Hee KIM ; Soo-Jin PARK ; Young-Ran YOON ; Sook Jin SEONG
Translational and Clinical Pharmacology 2023;31(2):105-113
Two open-label, randomized, two-period crossover studies were conducted to investigate the pharmacokinetic (PK) properties, safety, and bioequivalence of the test formulation (KD4004), a new fixed-dose combination (FDC) formulation of dapagliflozin and metformin extended release (XR) tablets, relative to the reference formulation (10 mg dapagliflozin/1,000 mg metformin XR FDC tablet) in healthy subjects under fasting (Part A) and fed (Part B) conditions. After giving the dose, serial blood samples were collected for a period of 48 hours. Primary PK parameters (AUC 0-t and C max ) were used to assess bioequivalence between two dapagliflozin/metformin XR (10/1,000 mg) FDC formulations under fed and fasting conditions. Safety and tolerability were also evaluated. Part A and Part B were completed by 32 and 37 subjects, respectively. Bioequivalence of the two FDC formulations of dapagliflozin and metformin XR tablets was established in both the fasted and the fed conditions as the 90% confidence interval of the ratios of adjusted geometric means for AUC 0-t and C max were contained within the predefined range of 0.800–1.250 bioequivalence criteria. Single-dose administration of dapagliflozin and metformin XR was safe and well tolerated as the two FDC formulations. In conclusion, both FDC formulations of dapagliflozin and metformin XR tablets were bioequivalent in fed and fasted subjects. All treatments were well tolerated.
8.Development of a Next-generation Sequencing-based Gene Panel Test to Detect Measurable Residual Disease in Acute Myeloid Leukemia
Jin Ju KIM ; Ji Eun JANG ; Hyeon Ah LEE ; Mi Ri PARK ; Hye Won KOOK ; Seung-Tae LEE ; Jong Rak CHOI ; Yoo Hong MIN ; Saeam SHIN ; June-Won CHEONG
Annals of Laboratory Medicine 2023;43(4):328-336
Background:
AML is a heterogeneous disease, and despite intensive therapy, recurrence is still high in AML patients who achieve the criterion for cytomorphologic remission (residual tumor burden [measurable residual disease, MRD]<5%). This study aimed to develop a targeted next-generation sequencing (NGS) panel to detect MRD in AML patients and validate its performance.
Methods:
We designed an error-corrected, targeted MRD-NGS panel without using physical molecular barcodes, including 24 genes. Fifty-four bone marrow and peripheral blood samples from 23 AML patients were sequenced using the panel. The panel design was validated using reference material, and accuracy was assessed using droplet digital PCR.
Results:
Dilution tests showed excellent linearity and a strong correlation between expected and observed clonal frequencies (R>0.99). The test reproducibly detected MRD in three dilution series samples, with a sensitivity of 0.25% for single-nucleotide variants. More than half of samples from patients with morphologic remission after one month of chemotherapy had detectable mutations. NGS-MRD positivity for samples collected after one month of chemotherapy tended to be associated with poor overall survival and progression-free survival.
Conclusions
Our highly sensitive and accurate NGS-MRD panel can be readily used to monitor most AML patients in clinical practice, including patients without gene rearrangement. In addition, this NGS-MRD panel may allow the detection of newly emerging clones during clinical relapse, leading to more reliable prognoses of AML.
9.Effective Timing of Introducing an Inpatient Smoking Cessation Program to Cancer Patients
Yu-Ri CHOE ; Ji-Won CHOI ; Ju-Ri JEONG ; Hye-Mi DOH ; Mi-Lee KIM ; Min-Seol NAM ; Hee-Ji KHO ; Ha-Young PARK ; Hye-Ran AHN ; Sun-Seog KWEON ; Yu-Il KIM ; In-Jae OH
Yonsei Medical Journal 2023;64(4):251-258
Purpose:
We aimed to identify factors influencing smoking cessation success among cancer patients registered in an inpatient smoking cessation program at a single cancer center.
Materials and Methods:
The electronic medical records of enrolled patients with solid cancer were retrospectively reviewed. We evaluated factors associated with 6-month smoking cessation.
Results:
A total of 458 patients with cancer were included in this study. Their mean age was 62.9±10.3 years, and 56.3% of the participants had lung cancer. 193 (42.1%) had not yet begun their main treatment. The mean number of counseling sessions for the participants was 8.4±3.5, and 46 (10.0%) patients were prescribed smoking cessation medications. The 6-month smoking cessation success rate was 48.0%. Multivariate analysis showed that younger age (<65 years), cohabited status, early stage, and the number of counseling sessions were statistically significant factors affecting 6-month smoking cessation success (p<0.05). Initiation of a cessation program before cancer treatment was significantly associated with cessation success (odds ratio, 1.66; 95% confidence interval, 1.02–2.70; p=0.040).
Conclusion
Smoking cessation intervention must be considered when establishing a treatment plan immediately after a cancer diagnosis among smokers.
10.Impact of Skeletal Muscle Loss and Visceral Obesity Measured Using Serial CT on the Prognosis of Operable Breast Cancers in Asian Patients
Mi-ri KWON ; Eun Sook KO ; Min Su PARK ; Woo Kyoung JEONG ; Na Young HWANG ; Jae-Hun KIM ; Jeong Eon LEE ; Seok Won KIM ; Jong Han YU ; Boo-Kyung HAN ; Eun Young KO ; Ji Soo CHOI ; Ko Woon PARK
Korean Journal of Radiology 2022;23(2):159-171
Objective:
This study aimed to investigate the impact of baseline values and temporal changes in body composition parameters, including skeletal muscle index (SMI) and visceral adipose tissue area (VAT), measured using serial computed tomography (CT) imaging on the prognosis of operable breast cancers in Asian patients.
Materials and Methods:
This study retrospectively included 627 Asian female (mean age ± standard deviation [SD], 53.6 ± 8.3 years) who underwent surgery for stage I–III breast cancer between January 2011 and September 2012. Body composition parameters, including SMI and VAT, were semi-automatically calculated on baseline abdominal CT at the time of diagnosis and follow-up CT for post-treatment surveillance. Serial changes in SMI and VAT were calculated as the delta values. Multivariable Cox regression analysis was used to evaluate the association of baseline and delta SMI and VAT values with disease-free survival.
Results:
Among 627 patients, 56 patients (9.2%) had breast cancer recurrence after a median of 40.5 months. The mean value ± SD of the baseline SMI and baseline VAT were 43.7 ± 5.8 cm2 /m2 and 72.0 ± 46.0 cm2 , respectively. The mean value of the delta SMI was -0.9 cm2 /m2 and the delta VAT was 0.5 cm2 . The baseline SMI and VAT were not significantly associated with disease-free survival (adjusted hazard ratio [HR], 0.983; 95% confidence interval [CI], 0.937–1.031; p = 0.475 and adjusted HR, 1.001; 95% CI, 0.995–1.006; p = 0.751, respectively). The delta SMI and VAT were also not significantly associated with disease-free survival (adjusted HR, 0.894; 95% CI, 0.766–1.043; p = 0.155 and adjusted HR, 1.001; 95% CI, 0.989–1.014; p = 0.848, respectively).
Conclusion
Our study revealed that baseline and early temporal changes in SMI and VAT were not independent prognostic factors regarding disease-free survival in Asian patients undergoing surgery for breast cancer.

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