Unlock the Cell: Castleman's Disease Flow Cytometry Study
NCT ID: NCT02853968
Last Updated: 2020-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
130 participants
OBSERVATIONAL
2016-02-29
2019-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Castleman's Patients
Castleman's patients with HHV8 negative multicentric MCD
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.
Related Disease Controls
Controls with inflammatory diseases similar to idiopathic multicentric Castleman's: i.e. HHV8+ MCD, HLH, Hodgkin disease
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.
Healthy Donor Controls
Healthy subjects used for controls. These healthy subjects have no history of autoimmune disorders.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Yes
Sponsors
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Castleman Disease Collaborative Network
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Vera Krymskaya, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Hunt I: Columbia Hunt Pathogen Study
Effectiveness of rituximab-containing treatment regimens in iMCD
iMCD International Treatment Guidelines
Other Identifiers
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823546
Identifier Type: -
Identifier Source: org_study_id
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