Clinical Trial: Unlock the Cell: Castleman's Disease Flow Cytometry Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: The purpose of this study is to study stained Castleman's Disease lymph nodes and perform flow cytometry and cell culture experiments on Castleman Disease blood samples to determine which cellular pathways and immune cell types are driving the disease.

Detailed Summary:

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.


Sponsor: University of Pennsylvania

Current Primary Outcome: Inflammatory cell profile [ Time Frame: an average of 1 year ]

Peripheral blood collected from MCD patients and control population will be analyzed via FACS analysis to determine specific cell types dysregulated in MCD compared to healthy subjects.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Pennsylvania

Dates:
Date Received: July 15, 2016
Date Started: May 2016
Date Completion: May 2018
Last Updated: August 8, 2016
Last Verified: August 2016