Observational Retrospective Multicenter Study for the Citofluorimetric Analysis of Cerebrospinal Fluid Vs Conventional Method in Patients With Aggressive Non-Hodgkin's Lymphoma Without Leptomeningeal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 12
- 主要终点
- Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.
研究概览
简要总结
The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.
详细描述
Aggressive B-cell non-Hodgkin's lymphoma (B-NHL), Lymphoblastic Lymphoma and Burkitt's Lymphoma are at high risk of CNS relapse. For this reason is recommended a prophylaxis therapy. This suggests that negative leptomeningeal localization patients at diagnosis are really positive and that would be a very high risk of CNS relapse subtype patients. It's very important detecting neoplastic cells in cerebrospinal fluid as soon as possible. This study will evaluate only patients that have been flow cytometry and cytology at diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of
- •Diffuse large cell lymphoma HIV positive,
- •Lymphoblastic lymphoma,
- •Burkitt's lymphoma,
- •Mantle cell lymphoma blastoid type.
- •DLCL patients who presented one risk factor for leptomeningeal involvement as:
- •testis, bone marrow, orbit, palate, paranasal cavity or peridural disease localization,
- •2-3 age-adjusted IPI score with more than 1 extranodal site and LDH > normal.
- •Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis.
排除标准
- •Patients with clinical or strumental evidence of meningeal localization disease.
结局指标
主要结局
Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology.
时间窗: Evaluation at diagnosis
Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology. The second test will be performed independently and without the cytologist is aware of the outcome of the analysis by flow cytometry.
次要结局
- Collection of all paper forms(1 year)