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临床试验/NCT02181049
NCT02181049进行中(未招募)不适用

Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach

CVSS study1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,000
试验地点
1
主要终点
Heart failure

研究概览

简要总结

Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. In particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. The CVSS study is a multi-disciplinary cooperation project between the Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. Therapy data will be extracted retrospectively from various sources. The study intends to describe the current situation of a cohort of approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health. The role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. The results will contribute to recommendations to improve follow-up care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
24 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Survivors of oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
  • Declaration of consent for storage of personal data at GCCR

排除标准

  • Patient has refused contact with GCCR
  • Current address not available
  • Second malignant neoplasm
  • Diagnosis Morbus Hodgkin
  • Diagnosis WILMS tumor in 1990
  • Former treating center recommends exclusion
  • Insufficient knowledge of German language
  • Inability to travel to the study center and participate in the examinations

结局指标

主要结局

Heart failure

时间窗: up to 35 years after exposure to childhood cancer therapy

Hypertension

时间窗: up to 35 years after exposure to childhood cancer therapy

次要结局

  • Myocardial infarction(up to 35 years after exposure to childhood cancer therapy)
  • Late-occurring stroke(up to 35 years after exposure to childhood cancer therapy)
  • Carotid artery disease(up to 35 years after exposure to childhood cancer therapy)

研究者

发起方
CVSS study
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

CVSS study

interdisciplinary cooperation

Johannes Gutenberg University Mainz

研究点 (1)

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