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临床试验/NCT02853968
NCT02853968已完成不适用

Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2016年2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
130
试验地点
1
主要终点
Collect PBMCs to use for inflammatory cell profiling via FACS

研究概览

简要总结

Castleman disease, a rare lymphoproliferative disorder, is characterized by inflammatory cytokine production and multiple organ system dysfunction. In this study, we will investigate inflammatory markers, cells, and signaling pathways in prospectively collected blood samples and/or buccal swabs or saliva using biochemical and RT-PCR techniques, proteomics, genomics, immunohistochemistry, storage for future use, cell culture treated with external stimuli, flow cytometry, and other molecular tests

详细描述

This is a University of Pennsylvania-sponsored project that is supported by the Castleman Disease Collaborative Network and the patients/loved one's group Castleman's Warriors (Castleman's Awareness and Research Effort).

Castleman Disease (CD) is a rare and poorly understood lymphoproliferative disease. The multicentric CD subtype (MCD) involves enlarged lymph nodes in multiple regions of the body and can be fatal if untreated. MCD patients demonstrate acute inflammatory crisis due to upregulation of inflammatory agents most notably IL-6 and VEGF followed by multiple organ failure and death.

Unlock the Cell aims to identify the pathways the disease takes through flow cytometry studies. The purpose of the CD Research study is to collect blood samples and/or buccal swabs or saliva samples and medical information of MCD patients and compare them to control samples so researchers can understand the causes of MCD, and design treatments based on our findings.

In this study, the investigators will analyze inflammatory markers, cells, and signaling pathways in prospectively collected blood samples using biochemical and RT-PCR techniques, proteomics, genomics, immunohistochemistry, storage for future use, cell culture treated with external stimuli, flow cytometry, and other molecular tests. A secondary aim is to collect excess stored tissue samples (e.g., lymph node, bone marrow) from previous procedures and store these samples along with unused blood samples for future research purposes to be performed at the University of Pennsylvania or shared with other Castleman disease researchers and biobanks.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • CD patients: Individuals of any age who are diagnosed with or suspected by a physician to have CD, including those who do have the ability to consent and those who lack the ability to consent
  • Related Disease: Individuals who state that they have a disease that is a "Related Disease". "Related Disease" means autoimmune, oncology, inflammatory/lymphoproliferative disorders and infectious diseases that are similar to Castleman
  • Healthy Individuals: Individuals without a history of auto-immune, inflammatory, infectious disease or oncologic disorders.

排除标准

  • All individuals whose medical or psychological conditions (such as a mental handicap) would, in the opinion of the Principal Investigator, compromise the subject's safety or successful participation in the study.

结局指标

主要结局

Collect PBMCs to use for inflammatory cell profiling via FACS

时间窗: 1 year ~

Peripheral blood will be collected to isolate peripheral blood mononuclear cells (PBMCs) used to look at inflammatory cell profiling via FACS. This will tell us what specific profiles are dysregulated.

Collect PBMCs to use for cell culture experiments

时间窗: 1 year ~

Peripheral blood will be collected to isolate peripheral blood mononuclear cells (PBMCs) for cell culture experiments.

次要结局

  • Use peripheral blood for biochemical testing(1 year ~)
  • Extract DNA and RNA from tissue samples to store in biobank(1 year ~)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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