Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Pattern of SMN subtypes
研究概览
简要总结
Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.
详细描述
To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with childhood acute lymphoblastic leukemia
- •Diagnosis of second cancer before December 31st 2007
排除标准
- •Uncertainty if the second cancer has emerged from the same original leukemic clone
结局指标
主要结局
Pattern of SMN subtypes
时间窗: At 20 years from diagnosis
Pattern of the main groups of SMN and their clinical charactiristics
Overall survival by subtype
时间窗: At 10 years from diagnosis of SMN
Overall survival by the main SMN subtypes (myeloid malignancies, brain tumors, lymphomas, sarcomas, carcinomas, others)
Risk factors for development of SMN
时间窗: At 20 years from ALL diagnosis
Identification of risk factors linked to the interval to SMN, the subtype of SMN, and the survival after. These risk factors are clinical characteristics of ALL or the anti-ALL therapy administered
次要结局
未报告次要终点
研究者
Kjeld Schmiegelow
Professor
Rigshospitalet, Denmark