Department of Clinical Research Design and Evaluation SAIHST, Sungkyunkwan University, 115 Irwon-ro, Gangnam, Seoul, 06335, South Korea.
Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.
Breast Cancer. 2024 May;31(3):467-475. doi: 10.1007/s12282-024-01559-5. Epub 2024 Mar 12.
In recognition of the distinct clinical challenges and research gaps in young breast cancer (YBC) patients, we established the Comprehensive Young Age Breast Cancer (CHARM) registry to collect prospective data.
This prospective cohort included patients who were newly diagnosed with histologically confirmed breast cancer without prior treatment at the Samsung Medical Center (SMC) in April 2013. We included patients who were either 40 years old or younger at the time of diagnosis, pregnant at breast cancer diagnosis or diagnosed with breast cancer within 1 year of delivery. All data were collected using Medidata's Rave Electronic Data. Clinical data were obtained from electronic medical records. Two experienced pathologists reviewed the pathologic data. Bone mineral densitometry tests have been conducted annually. To obtain multi-omics data, tumor tissues and blood samples were prospectively collected from consenting patients in the registry during surgery. The fertility-related factor also collected collaborated with the Department of Obstetrics and Gynecology. Anti-Müllerian hormone, estradiol, follicle-stimulating hormone, and luteinizing hormone levels were measured using an additional blood sample from baseline to last follow-up. Patient-reported outcomes were assessed using mobile questionnaires.
A total of 1868 participants were included in the SMC YBC study. The average (standard deviation) age was 35.57 (3.79) and 99.8% of the participants were premenopausal. Among them, 1062 participants completed the PRO questionnaires.
The SMC YBC cohort serves as a comprehensive registry for YBC to optimize care and improve knowledge regarding the management of YBC.
鉴于年轻乳腺癌（YBC）患者存在明显的临床挑战和研究空白，我们建立了综合年轻乳腺癌（CHARM）登记处，以收集前瞻性数据。
这项前瞻性队列研究纳入了 2013 年 4 月在三星医疗中心（SMC）新诊断为组织学确诊乳腺癌且未经治疗的患者。我们纳入的患者在诊断时年龄为 40 岁或以下、在乳腺癌诊断时怀孕或在分娩后 1 年内诊断为乳腺癌。所有数据均使用 Medidata 的 Rave 电子数据收集。临床数据来自电子病历。两名经验丰富的病理学家对病理数据进行了复查。每年进行骨矿物质密度检测。为了获得多组学数据，在登记处的手术期间，从同意的患者中前瞻性地收集肿瘤组织和血液样本。与妇产科合作收集与生育有关的因素。使用基线至最后一次随访期间的额外血液样本测量抗苗勒管激素、雌二醇、卵泡刺激素和黄体生成素水平。使用移动问卷调查评估患者报告的结果。
SMC YBC 研究共纳入 1868 名参与者。平均（标准差）年龄为 35.57（3.79），99.8%的参与者处于绝经前状态。其中，1062 名参与者完成了 PRO 问卷。
SMC YBC 队列是 YBC 的综合登记处，旨在优化 YBC 的护理，并提高对 YBC 管理的认识。
