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临床试验/NCT03803670
NCT03803670已完成不适用

Clinical Significance of Occult Central Nervous System Disease In Adult Acute Lymphoblastic Leukemia: A Multicenter, Retrospective Study From The Campus All/Gimema Network

University of Rome Tor Vergata0 个研究点目标入组 241 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
241
主要终点
impact of occult CNS disease on outcome

研究概览

简要总结

Central nervous system involvement at diagnosis remains an obstacle to a long-term cure of patients affected by acute lymphoblastic leukemia. The investigators have previously reported that flow cytometry (FCM) is better than conventional cytology (CC) in demonstrating the presence of leukemic cells in the patients'(pts) cerebrospinal fluid (CSF), especially in samples with low cell counts. In the framework of the national Campus ALL program aimed at improving the management of adult ALL patients in the context of the GIMEMA protocols, in the present study the investigators retrospectively evaluated the incidence of occult CNS positivity and its impact on outcome in 241 adult pts with newly diagnosed ALL from 13 centers.

详细描述

Demographic and of laboratory data of 241 adult patients with ALL were retrospectively recorded. All patients underwent diagnostic lumbar puncture and each cerebrospinal fluid sample was examined by CC and FCM. The investigators identified patients with the only FCM positivity and the investigators correlated this condition with clinical and of laboratory data and with clinical outcome.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • ALL at onset
  • Age >18 years

排除标准

  • ALL relapsed or refractory
  • Age <18 years

结局指标

主要结局

impact of occult CNS disease on outcome

时间窗: 10 years

overall survival

impact of occult CNS disease

时间窗: 10 years

relapse rate

次要结局

未报告次要终点

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Ilaria Del Principe

PI

University of Rome Tor Vergata

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