Unlock the Cell: Castleman's Disease Flow Cytometry Study

Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853968
• Other study ID #: 823546
• Status: Completed
• Start date: February 2016
• Est. completion date: March 30, 2019

Study information

• Verified date: March 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Angiofollicular Lymph Hyperplasia
• Angiofollicular Lymphoid Hyperplasia
• Castleman Disease
• Castleman's Disease
• Giant Lymph Node Hyperplasia
• GLNH
• Hyperplasia

Intervention

Procedure:
• Blood draw/buccal swab
The research project will need a blood sample of no more than 50mL per two month period. The research project may also request a buccal swab from patients if needed.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Castleman Disease Collaborative Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect PBMCs to use for inflammatory cell profiling via FACS	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.	1 year ~
Primary	Collect PBMCs to use for cell culture experiments	Peripheral blood will be collected to isolate peripheral blood mononuclear cells (PBMCs) for cell culture experiments.	1 year ~
Secondary	Use peripheral blood for biochemical testing	Biochemical testing will be performed on blood samples to collect inflammatory gene expressions using qPCR, ELISA and immunoblot.	1 year ~
Secondary	Extract DNA and RNA from tissue samples to store in biobank	Excess blood sample tubes and/or buccal swabs or saliva will have DNA and RNA extracted and serum and plasma separated out to be stored in our biobank for future research.	1 year ~

External Links

•   Effectiveness of rituximab-containing treatment regimens in iMCD
•   Hunt I: Columbia Hunt Pathogen Study
•   iMCD International Treatment Guidelines
•   International Diagnostic Criteria
•   Novel insights and therapeutic approaches in iMCD
•   Predictors of response to siltuximab
•   Systematic Lit Review of iMCD
•   The full spectrum of Castleman Disease: 273 patients studied over 20 years