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Unlock the Cell: Castleman's Disease Flow Cytometry Study

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ClinicalTrials.gov Identifier: NCT02853968
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Castleman Disease Collaborative Network
Information provided by (Responsible Party):
University of Pennsylvania

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

Condition or disease Intervention/treatment
Castleman Disease Angiofollicular Lymphoid Hyperplasia GLNH Hyperplasia Castleman's Disease Angiofollicular Lymph Hyperplasia Giant Lymph Node Hyperplasia Procedure: Blood draw/buccal swab

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.

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease
Actual Study Start Date : February 2016
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : March 30, 2019


Group/Cohort Intervention/treatment
Castleman's Patients
Castleman's patients with HHV8 negative multicentric MCD
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.

Related Disease Controls
Controls with inflammatory diseases similar to idiopathic multicentric Castleman's: i.e. HHV8+ MCD, HLH, Hodgkin disease
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.

Healthy Donor Controls
Healthy subjects used for controls. These healthy subjects have no history of autoimmune disorders.
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.




Primary Outcome Measures :
  1. Collect PBMCs to use for inflammatory cell profiling via FACS [ Time Frame: 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.

  2. Collect PBMCs to use for cell culture experiments [ Time Frame: 1 year ~ ]
    Peripheral blood will be collected to isolate peripheral blood mononuclear cells (PBMCs) for cell culture experiments.


Secondary Outcome Measures :
  1. Use peripheral blood for biochemical testing [ Time Frame: 1 year ~ ]
    Biochemical testing will be performed on blood samples to collect inflammatory gene expressions using qPCR, ELISA and immunoblot.

  2. Extract DNA and RNA from tissue samples to store in biobank [ Time Frame: 1 year ~ ]
    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.


Biospecimen Retention:   Samples With DNA
Our primary aim is to generate data to help to understand MCD pathogenesis, specifically: 1) what cells secrete cytokines, 2) what signaling pathways are activated, 3) what cytokines are released, and 4) what triggers this upregulation resulting in acute inflammation. We will investigate these 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. We also want to collect excess stored tissue samples from previous procedures and store these samples along with unused blood samples and/or buccal swabs or saliva for future research purposes.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853968


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Castleman Disease Collaborative Network
Investigators
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Principal Investigator: Vera Krymskaya, PhD, MBA University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Additional Information:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02853968    
Other Study ID Numbers: 823546
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified Researchers, who apply for access to the data and are subsequently approved, will be given access to a limited dataset with direct identifiers removed in an Excel compatible file format or single SAS data files.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Keywords provided by University of Pennsylvania:
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
Additional relevant MeSH terms:
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Castleman Disease
Lymphadenopathy
Hyperplasia
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases