Schindera Christina, Kuehni Claudia Elisabeth, Pavlovic Mladen, Haegler-Laube Eva Simona, Rhyner Daniel, Waespe Nicolas, Roessler Jochen, Suter Thomas, von der Weid Nicolas Xavier
Childhood Cancer Registry, Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Pediatric Oncology/Hematology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.
JMIR Res Protoc. 2020 Jun 10;9(6):e17724. doi: 10.2196/17724.
Cardiovascular disease is the leading nonmalignant cause of late deaths in childhood cancer survivors. Cardiovascular disease and cardiac dysfunction can remain asymptomatic for many years, but eventually lead to progressive disease with high morbidity and mortality. Early detection and intervention are therefore crucial to improve outcomes.
In our study, we aim to assess the prevalence of preclinical cardiac dysfunction in adult childhood cancer survivors using conventional and speckle tracking echocardiography; determine the association between cardiac dysfunction and treatment-related risk factors (anthracyclines, alkylating agents, steroids, cardiac radiation) and modifiable cardiovascular risk factors (abdominal obesity, hypertension); investigate the development of cardiac dysfunction longitudinally in a defined cohort; study the association between cardiac dysfunction and other health outcomes like pulmonary disease, endocrine disease, renal disease, quality of life, fatigue, strength and endurance, and physical activity; and gain experience conducting a clinical study of childhood cancer survivors that will be extended to a national, multicenter study of cardiac complications.
For this retrospective cohort study, we will invite ≥5-year childhood cancer survivors who were treated at the University Children's Hospital Bern, Switzerland with any chemotherapy or cardiac radiation since 1976 and who are ≥18 years of age at the time of the study for a cardiac assessment at the University Hospital Bern. This includes 544 childhood cancer survivors, of whom about half were treated with anthracyclines and/or cardiac radiation and half with any other chemotherapy. The standardized cardiac assessment includes a medical history focusing on signs of cardiovascular disease and its risk factors, a physical examination, anthropometry, vital parameters, the 1-minute sit-to-stand test, and echocardiography including 2-dimensional speckle tracking.
We will invite 544 eligible childhood cancer survivors (median age at the time of the study, 32.5 years; median length of time since diagnosis, 25.0 years) for a cardiac assessment. Of these survivors, 300 (55%) are at high risk, and 244 (45%) are at standard risk of cardiac dysfunction.
This study will determine the prevalence of preclinical cardiac dysfunction in Swiss childhood cancer survivors, inform whether speckle tracking echocardiography is more sensitive to cardiac dysfunction than conventional echocardiography, and give a detailed picture of risk factors for cardiac dysfunction. The results will help improve primary treatment and follow-up care of children with cancer.
ClinicalTrials.gov NCT03790943; https://clinicaltrials.gov/ct2/show/NCT03790943.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17724.
心血管疾病是儿童癌症幸存者晚期死亡的主要非恶性原因。心血管疾病和心脏功能障碍可能多年无症状，但最终会导致疾病进展，发病率和死亡率很高。因此，早期发现和干预对于改善预后至关重要。
在我们的研究中，我们旨在使用传统超声心动图和斑点追踪超声心动图评估成年期儿童癌症幸存者临床前期心脏功能障碍的患病率；确定心脏功能障碍与治疗相关风险因素（蒽环类药物、烷化剂、类固醇、心脏放疗）和可改变的心血管风险因素（腹型肥胖、高血压）之间的关联；纵向研究特定队列中心脏功能障碍的发展；研究心脏功能障碍与其他健康结局（如肺部疾病、内分泌疾病、肾脏疾病、生活质量、疲劳、力量和耐力以及身体活动）之间的关联；并积累开展儿童癌症幸存者临床研究的经验，该研究将扩展为一项关于心脏并发症的全国性多中心研究。
对于这项回顾性队列研究，我们将邀请自1976年以来在瑞士伯尔尼大学儿童医院接受过任何化疗或心脏放疗且在研究时年龄≥18岁的≥5年儿童癌症幸存者到伯尔尼大学医院进行心脏评估。这包括544名儿童癌症幸存者，其中约一半接受过蒽环类药物和/或心脏放疗，另一半接受过任何其他化疗。标准化的心脏评估包括关注心血管疾病体征及其风险因素的病史、体格检查、人体测量、生命体征参数、1分钟坐立试验以及包括二维斑点追踪的超声心动图检查。
我们将邀请544名符合条件的儿童癌症幸存者（研究时的中位年龄为32.5岁；自诊断以来的中位时间为25.0年）进行心脏评估。在这些幸存者中，300名（55%）处于心脏功能障碍的高风险，244名（45%）处于标准风险。
本研究将确定瑞士儿童癌症幸存者临床前期心脏功能障碍的患病率，了解斑点追踪超声心动图是否比传统超声心动图对心脏功能障碍更敏感，并详细描绘心脏功能障碍的风险因素。研究结果将有助于改善儿童癌症的初始治疗和后续护理。
ClinicalTrials.gov NCT03790943；https://clinicaltrials.gov/ct2/show/NCT03790943。
国际注册报告识别码（IRRID）：DERR1-10.2196/17724。
