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临床试验/NCT01030913
NCT01030913已完成不适用

B-CLL Subgroups: Maturation Stage and Gene Expression

Northwell Health1 个研究点 分布在 1 个国家目标入组 1,248 人开始时间: 1999年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,248
试验地点
1
主要终点
differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the difference in clinical disease course and outcome for each group

研究概览

简要总结

B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age,
  • Patients must be able to contribute the required amount of blood without compromising their well being,
  • Participants must be willing to be contacted again in the future for additional blood drawing.

排除标准

  • Patients who are known to be anemic, with a hemoglobin < 8,
  • Patients who are known to be infected with HIV.

结局指标

主要结局

differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the difference in clinical disease course and outcome for each group

时间窗: follow through the clinical disease course for each group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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