NCT00981097已完成不适用
Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
AIDS Malignancy Consortium16 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 16
- 主要终点
- Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
研究概览
简要总结
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.
详细描述
OBJECTIVES:
Primary
- To estimate the proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC).
- To estimate the proportion of patients with Hodgkin lymphoma with clonal immunoglobulin (Ig) DNA detection in the plasma.
Secondary
- To estimate the agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue.
- To estimate the agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma.
- To estimate the detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma.
- To estimate the detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma.
- To analyze clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki-67 index.
- To estimate the detection rate of clonotypic B-cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma
时间窗: Study entry
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
时间窗: Study entry
次要结局
- Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma(Study entry)
- Analysis of the clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki67 index(Study entry)
- Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma(Study entry)
- Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue(Study entry)
- Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma(Study entry)
- Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma(Study entry)
研究者
研究点 (16)
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