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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

Tracking Information
First Submitted Date July 15, 2016
First Posted Date August 3, 2016
Last Update Posted Date March 26, 2020
Actual Study Start Date February 2016
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: July 29, 2016)
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.
Change History
Current Secondary Outcome Measures
 (submitted: March 24, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition
  • Castleman Disease
  • Angiofollicular Lymphoid Hyperplasia
  • GLNH
  • Hyperplasia
  • Castleman's Disease
  • Angiofollicular Lymph Hyperplasia
  • Giant Lymph Node 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.
Study Groups/Cohorts
  • Castleman's Patients
    Castleman's patients with HHV8 negative multicentric MCD
    Intervention: Procedure: Blood draw/buccal swab
  • Related Disease Controls
    Controls with inflammatory diseases similar to idiopathic multicentric Castleman's: i.e. HHV8+ MCD, HLH, Hodgkin disease
    Intervention: Procedure: Blood draw/buccal swab
  • Healthy Donor Controls
    Healthy subjects used for controls. These healthy subjects have no history of autoimmune disorders.
    Intervention: Procedure: Blood draw/buccal swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 24, 2020)
130
Original Estimated Enrollment
 (submitted: July 29, 2016)
70
Actual Study Completion Date March 30, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
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.

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02853968
Other Study ID Numbers 823546
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
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
Supporting Materials: Informed Consent Form (ICF)
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Castleman Disease Collaborative Network
Investigators
Principal Investigator: Vera Krymskaya, PhD, MBA University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2020