Han Jiyoon, Lee Genehee, Cho Juhee, You Somin, Shim Young Mog, Choi Yong Soo, Cho Jong Ho, Park Seong Yong, Jeon Yeong Jeong, Lee Junghee, Kang Danbee, Kim Hong Kwan
Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Republic of Korea.
Center for Clinical Epidemiology, Samsung Medical Center, Seoul, Republic of Korea.
Front Oncol. 2025 Jul 23;15:1607741. doi: 10.3389/fonc.2025.1607741. eCollection 2025.
Although esophageal cancer survivors experience lower health-related quality of life (HRQoL), it is hard to provide proper supportive care due to difficulties to find potential target population. This study aims to develop a trial-ready cohort (TRC) to assess the unmet needs and HRQoL of survivors of esophageal cancer. This prospective, multicenter TRC study will include 600 patients diagnosed with primary esophageal cancer who have undergone curative treatment. Exclusion criteria include the presence of synchronous malignancies, severe cognitive impairment, and residence outside of Korea. Patients are recruited from both existing cohort studies and newly diagnosed cases beginning in June 2023. At the time of enrollment into the TRC, participants provide informed consent, including agreement to be contacted and considered for relevant clinical trials when suitable interventions become available. Data is collected across five domains: sociodemographic characteristics, health behaviors, disease and treatment information, nutritional status, and quality of life. Study visits are scheduled at diagnosis, prior to surgery, at 1, 3, 6, and 12 months post-surgery, and annually thereafter for up to 10 years. As of June 2025, a total of 448 participants have been enrolled, representing approximately 75% of the target. To achieve this, our TRC employs three key strategies. First, we leverage three existing prospective studies to efficiently identify and enroll long-term survivors. Second, we collect a wide range of data on HRQoL, health behaviors, and environmental factors to enable a multidimensional understanding of survivorship. Third, we collect multiple times within short-term interval points, allowing seamless linkage between the cohort and appropriate trials. This study effectively designs a trial-ready cohort of survivors of esophageal cancer using a unique strategy to overcome cohort construction challenges, aiming to generate valuable data on quality of life and serve as a platform for tailored interventions.
尽管食管癌幸存者的健康相关生活质量(HRQoL)较低,但由于难以找到潜在的目标人群,因此很难提供适当的支持性护理。本研究旨在建立一个可供试验的队列(TRC),以评估食管癌幸存者未满足的需求和HRQoL。这项前瞻性、多中心的TRC研究将纳入600例接受了根治性治疗的原发性食管癌患者。排除标准包括存在同步恶性肿瘤、严重认知障碍以及居住在韩国境外。患者从现有的队列研究和2023年6月开始的新诊断病例中招募。在纳入TRC时,参与者提供知情同意书,包括同意在有合适干预措施时被联系并考虑参与相关临床试验。数据收集涵盖五个领域:社会人口学特征、健康行为、疾病和治疗信息、营养状况以及生活质量。研究访视安排在诊断时、手术前、手术后1、3、6和12个月,此后每年进行一次,最长持续10年。截至2025年6月,共招募了448名参与者,约占目标人数的75%。为实现这一目标,我们的TRC采用了三项关键策略。首先,我们利用三项现有的前瞻性研究来有效识别和招募长期幸存者。其次,我们收集关于HRQoL、健康行为和环境因素的广泛数据,以便从多维度理解生存情况。第三,我们在短期时间间隔内多次收集数据,使队列与适当的试验能够无缝衔接。本研究采用独特策略有效设计了一个可供试验的食管癌幸存者队列,以克服队列构建挑战,旨在生成关于生活质量的有价值数据,并作为量身定制干预措施的平台。