Impact of Congenital Heart Disease on Quality of Life and Long-Term Outcomes in Childhood Hematological Tumor Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 18
- 主要终点
- Occurrence of all-cause death
研究概览
简要总结
This study aims to determine whether congenital heart disease increases chronic health risks and mortality in childhood hematological tumor survivors, explore potential shared genetic factors between these conditions, identify other factors affecting long-term outcomes and quality of life, and validate any discovered genetic links through mechanistic investigations.
详细描述
Children with congenital heart disease have a significantly higher risk of developing hematological tumors compared to the general pediatric population, although the clinical characteristics and prognosis of such comorbid cases have previously lacked systematic investigation. The study is set to include children with comorbid congenital heart disease and hematological tumors, comparing them with those without congenital heart disease, to conduct a detailed analysis of their clinical data, treatment responses, and survival outcomes.
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
- 0 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with hematologic malignancies diagnosed by pathology or bone marrow aspiration/biopsy at member hospitals of the Hematologic Oncology Specialty Alliance between 2010 and 2025;
- •Aged 0-17 years at diagnosis, regardless of gender;
- •Completed standard treatment for hematologic malignancies and confirmed diagnosis of congenital heart disease by cardiac ultrasound and clinical evaluation;
- •Written informed consent can be provided by the child or their legal guardian.
排除标准
- •Presence of birth defects other than congenital heart disease;
- •Other serious cardiac conditions, malignancies, or comorbidities that may interfere with study results;
- •Inability to provide the information and data required for the study.
结局指标
主要结局
Occurrence of all-cause death
时间窗: from enrollment to follow-up for 5 year
Frequency and severity of SAEs assessed by CTCAE v5.0
时间窗: from enrollment to follow-up for 5 year
CommonTerminology Criteria for Adverse Events（CTCAE）has 5 levels of AE determination, increasing in severity as the level increases
次要结局
未报告次要终点