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Protocol and Cohort Profile of a Prospective Multicenter Lymphoma Cohort in South Korea
Danbee Kang1, Kunye Kwak2, Ka-Won Kang2
1Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, Korea; Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; Trend sensing-Risk modeling Center, Institution of Quality of Life in Cancer, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Background:
Real-world data are increasingly used to support pragmatic clinical trials. However, most existing oncology cohorts lack high-frequency symptom data and standardized infrastructures required for longitudinal outcome assessment.
Objective:
To describe the design of a prospective multicenter lymphoma cohort integrating patient-reported outcomes (PRO) to support future pragmatic trials.
Methods:
This ongoing cohort integrates data from institutional lymphoma registries established in 2010 and a multicenter prospective expansion initiated in April 2023. All participants provided written informed consent under the registry or multicenter cohort protocol applicable at the time of enrollment. Standardized electronic case report forms capture demographic, clinical, laboratory, and treatment information. PRO are collected using a mobile web-based platform. High-frequency symptom assessments are conducted using the PRO-CTCAE system at seven predefined time points per chemotherapy cycle. Data quality is maintained through predefined coding schemes, automated validation checks, and regular audits. Vital status is ascertained through linkage with national mortality data.
Results:
Among 2,370 enrolled patients, 143 had Hodgkin lymphoma, 1,726 had B-cell non-Hodgkin lymphoma, and 501 had T- or NK-cell non-Hodgkin lymphoma. The high-frequency symptom data enable longitudinal assessment of treatment-related symptom trajectories across chemotherapy cycles.
Conclusions:
This cohort integrates standardized clinical data with high-frequency patient-reported outcomes in a real-world setting. The data structure and prospective design may support future pragmatic trials by enabling longitudinal outcome assessment and patient-centered monitoring.