NCT05071001已完成不适用
Long Term Brain Toxicity of Chemotherapy in Patients Treated for a Bone TumorDuring Childhood or Adolescence
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- scores obtained in FactCOG as a whole and in each subscale
研究概览
简要总结
To assess the neurocognitive outcomes in patients treated with chemotherapy for a malignant bone tumor during childhood and adolescence and the factors associated with neurocognitive impairment and/or complaints
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •For study OSE A and B
- •Patients treated for a bone sarcoma: Ewing or osteosarcoma
- •Age under 19 years at initial diagnosis
- •Treated in the Pediatric Oncology Department of Gustave
- •For patients diagnosed between 01.01.2001 and 31.12.2010: patients alive in complete remission at least 5 years after diagnosis
- •Treated with at least one course of HDMTX for osteosarcoma
- •Treated without HDMTX for Ewing sarcoma
- •Time interval between the end of treatment and inclusion >10 y
- •Age > 21 y at inclusion
- •Patients with informed consent signed
- •Patient under guardianship
- •Affiliated to French health insurance or beneficiary of the same or equivalent
- •For study OSE- B only:
- •Treated with at least 8 courses of HDMTX for osteosarcoma
- •Treated without HDMTX for Ewing sarcoma
- •Patients with Ewing sarcoma will have to be matched with osteosarcoma patients according to age at the time of treatment, sex, and duration of follow-up
- •School level equivalent of at least the end of primary school
排除标准
- •For study OSE A and B
- •Brain radiotherapy
- •Previous relapse except those treated by local treatment without any chemotherapy
- •Second malignancy treated with chemotherapy
- •High dose chemotherapy with stem cell support
- •Non-French speaking patients
- •Pregnant and breastfeeding women
- •For study OSE- B only:
- •- Patient deprived of his liberty by a judicial or administrative decision
研究组 & 干预措施
A
Experimental
干预措施: MRI (Procedure)
B
Experimental
干预措施: MRI (Procedure)
结局指标
主要结局
scores obtained in FactCOG as a whole and in each subscale
时间窗: 3 years
Primary analysis will be performed on all patients included in the study, including history of Ewing (treated without HDMTX) and osteosarcoma (treated with HDMTX). This population is the main analysis population of the study.
次要结局
未报告次要终点
研究者
研究点 (1)
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