NCT01715961已完成不适用
Multicentric Prospective Study to Assess the Clinical and Prognostic Value of Sarcopenia in Patients Older Than 70 Years With Diffuse Large B-cell Lymphoma
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
- 98
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
This clinical trial is a multicentric prospective study to assess the clinical and prognostic value of sarcopenia in patients older than 70 years with diffuse large B-cell lymphoma.
详细描述
Sarcopenia status is assessed by CT scan imaging on the overall survival at 18 months in patients older than 70 years with diffuse large B-cell lymphoma treated by R-CHOP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 70 years
- •DLBCL, grade IIIB follicular lymphoma or histologically proven transformed low grade lymphoma
- •Whatever the IPI score and the performance status
- •Treated by Rituximab-CHOP or Rituximab-mini-CHOP
- •CT scan imaging performed one month or less before inclusion
- •Signed informed consent
排除标准
- •No initial CT scan imaging performed more than one month before inclusion
- •Positivity for HCV, HBV and HIV
- •Anthracycline contra-indication
研究组 & 干预措施
anthropometric measurement
Other
The muscle area assessed by CT scan imaging at a lumbar vertebral landmark (L3) at the time of diagnosis, at the end of treatment, at 12 and 18 months
- anthropometric measures (weight, height, BMI, brachial and calf circumference) and MNA (mini nutritional assessment)
- albuminemia, transthyretin, orosomucoid, CRP
- functional test to attest the muscular strength: hand grip test, unipodal test, up and go test
- hematological and non-hematological chemotherapy toxicities of cycle 1 and cycle 2
- OS and PFS at 18 and 24 months
- GCB and ABC phenotypes determined by immunohistochemistry and transcriptome analysis
干预措施: anthropometric measurement (Procedure)
结局指标
主要结局
progression free survival
时间窗: at 18 months
次要结局
- progression free survival(at 24 months)
- rate of over grade 2 toxicities(at the first and second courses of chemotherapy (day 21 and day 42))
- determination of both molecular subtypes GCB and ABC(at 24 months)
研究者
研究点 (1)
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