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Lymphocyte Profiles and Activation Status in Patients With Graft-Versus-Host Disease

2015年2月26日 更新者:Samantha Jaglowski、Ohio State University Comprehensive Cancer Center

Lymphocyte Profiles and Activation Status in the Development of Chronic Graft-versus-Host Disease

This research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. Studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.

研究概览

详细说明

PRIMARY OBJECTIVES:

I. To explore and assess changes in subsets and activation status of B-, T,-, and natural killer (NK) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings.

SECONDARY OBJECTIVES:

I. To assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cGVHD) with time-matched stem cell transplant (SCT) patients without cGVHD and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses.

II. To assess and explore differences in lymphocyte subsets (B-, T-, and NK) between those with vs. without cGVHD.

III. To assess and explore differences in cytokines in patients with cGVHD vs. those without.

IV. To describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cGVHD.

OUTLINE:

Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (ELISA), enzyme-linked immunosorbent spot (ELISPOT), immunoblot, and microarray assays.

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients who have received an autologous stem cell transplant and stem cell transplant at The Ohio State University.

描述

Inclusion Criteria:

  • Allogeneic SCT groups: Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic graft-versus-host disease (GVHD)
  • Autologous SCT group: Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Allogeneic SCT Groups
Patients who have received stem cell transplantation at The Ohio State University are eligible and who are at or beyond day +75 following allogeneic SCT regardless of previous diagnosis of acute or chronic GVHD.
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
其他名称:
  • 实验室生物标志物分析
  • Correlatives studies
Autologous SCT group
Patients who have received an autologous stem cell transplant at The Ohio State University and who have achieved platelet and neutrophil engraftment.
Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
其他名称:
  • 实验室生物标志物分析
  • Correlatives studies

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Subsets and activation status of B, T, and NK lymphocytes
大体时间:Up to 2 months
Side by side box plots with overlaid plotted points will be used to assess potential differences in continuous markers between groups.
Up to 2 months

次要结果测量

结果测量
大体时间
Logistical challenges with obtaining and processing samples in each of the subgroups of interest
大体时间:Up to 2 months
Up to 2 months
Differences in lymphocyte subsets (B, T, and NK) between those with vs. without cGVHD
大体时间:Up to 2 months
Up to 2 months
Differences in cytokines in patients with cGVHD vs. those without
大体时间:Up to 2 months
Up to 2 months
Differences in in lymphocyte activation between those with vs. without cGVHD
大体时间:Up to 2 months
Up to 2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Samantha Jaglowski, MD、Ohio State University Comprehensive Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (预期的)

2016年12月1日

研究注册日期

首次提交

2013年11月14日

首先提交符合 QC 标准的

2013年11月14日

首次发布 (估计)

2013年11月20日

研究记录更新

最后更新发布 (估计)

2015年3月2日

上次提交的符合 QC 标准的更新

2015年2月26日

最后验证

2015年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OSU-12208
  • NCI-2013-01641 (注册表标识符:CTRP (Clinical Trial Reporting Program))

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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