Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Test results to assess organ-specific late effects (example of cardiac health)
研究概览
简要总结
The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.
详细描述
Background:
Around 250-300 children and adolescents below the age of 21 years are newly diagnosed with cancer in Switzerland every year. Research led to remarkable progress in survival in the last decades. The 10-year survival rate in Switzerland is currently 87%. Previous research showed that, depending on the treatment exposure, a high proportion of these survivors suffer from chronic medical conditions, so called late effects.
Many studies on late effects in former childhood cancer patients are based on retrospective data. However, this type of study design has unavoidable limitations, such as missing data, different coding and grading of severity of late effects, and the assessment at different time points. Therefore, we need prospectively collected data, including severity coding in a standardized way, to overcome these limitations.
Objectives:
The overarching aim of "Young Survivors at Kantonsspital Aarau, Switzerland" is to assess late effects in childhood cancer survivors prospectively and in a standardized way. These data will contribute to the increasing knowledge on long-term outcomes and late effects in the future. This new knowledge is important in order to be able to adapt and improve long-term follow-up care. In the longer term, survivors will benefit from this extensive and prospective data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents who:
- •have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau,
- •have been diagnosed at age 0-18 years,
- •are still in regular follow-up care at the Kantonsspital Aarau,
- •have finished cancer treatment and entered follow-up care, and
- •signed informed consent
- •Adolescents and adults who:
- •fulfill the same inclusion criteria as Group A
- •are not in regular follow-up care anymore
排除标准
- •Childhood Cancer Survivors who:
- •are in a palliative situation or
- •have not given consent for further use of medical data
结局指标
主要结局
Test results to assess organ-specific late effects (example of cardiac health)
时间窗: at recruitment or 2016 onwards, whichever comes first
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects
次要结局
- Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )(at recruitment or 2016 onwards, whichever comes first)
- Test results to assess organ-specific late effects (example of cardiac health)(annually from recruitment or 2016 onwards, whichever comes first)
- Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)(at recruitment or 2016 onwards, whichever comes first)
- Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)(annually from recruitment or 2016 onwards, whichever comes first)
- Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects(annually from recruitment or 2016 onwards, whichever comes first)
研究者
Katrin Scheinemann
Division Head of Pediatric Oncology-Hematology
Kantonsspital Aarau