Prospective Single Center Cohort Study for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 12
- 主要终点
- Treatment-related risk factors
研究概览
简要总结
This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can be detected earlier when using speckle tracking echocardiography as novel echocardiographic technique compared to conventional echocardiography.
详细描述
Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardized cardiac assessment including conventional and novel echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had chemotherapy other than anthracyclines (standard risk).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a national, population-based cancer registry that includes all children and adolescents in Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid tumours or Langerhans cell histiocytosis. Childhood cancer survivors have survived at least 5 years from cancer diagnosis.
- •Inclusion Criteria:
- •Registered in the ChCR
- •Formerly treated at the Department of Pediatric Hematology/Oncology of one of five participating centers
- •Treated with any chemotherapy and/or chest radiation
- •Survived ≥ 5 years since most recent cancer diagnosis (primary cancer, relapse(s), secondary cancer) at time of examination
- •Diagnosed at age ≤ 20 years
- •≥ 18 years of age at time of study participation
- •Resident in Switzerland
- •Written informed consent
排除标准
- •Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.
结局指标
主要结局
Treatment-related risk factors
时间窗: Baseline
Cumulative doses of anthracyclines, steroids, and alkylating agents (mg/m2)
Prevalence of impaired exercise capacity
时间窗: Baseline
Cardiopulmonary exercise testing: peak oxygen consumption, percent-predicted carbon dioxide production
Prevalence of cardiac dysfunction
时间窗: Baseline and longitudinal follow-up where clinically indicated
Conventional echocardiography: left ventricular ejection fraction (%)
次要结局
未报告次要终点