Clinical trial NCT02853968: Unlock the Cell: Castleman's Disease Flow Cytometry Study
Official title: Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castleman Disease
Angiofollicular Lymphoid Hyperplasia
GLNH
Hyperplasia
Castleman's Disease
Angiofollicular Lymph Hyperplasia
Giant Lymph Node Hyperplasia
Keywords: Unlock the Cell
Castleman's Disease
CD
Castleman Disease
MCD
iMCD
Angiofollicular Lymph Hyperplasia
multicentric Castleman's disease
multicentric Castleman disease
idiopathic multicentric Castleman disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Castleman Disease Collaborative Network
First posted: 2016-08-03
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals of any age (including those younger than 7 years of age), gender and ethnicity who have been diagnosed with CD

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Collect PBMCs to use for inflammatory cell profiling via FACS
timeFrame: 1 year ~
measure: Collect PBMCs to use for cell culture experiments
timeFrame: 1 year ~
Secondary outcomes:
measure: Use peripheral blood for biochemical testing
timeFrame: 1 year ~
measure: Extract DNA and RNA from tissue samples to store in biobank
timeFrame: 1 year ~
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Vera Krymskaya, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: