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Unlock the Cell: Castleman's Disease Flow Cytometry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02853968
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2018
Castleman Disease Collaborative Network
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to study stained Castleman's Disease lymph nodes and perform flow cytometry and cell culture experiments on Castleman Disease blood samples to determine which cellular pathways and immune cell types are driving the disease.

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
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease
Study Start Date : May 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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.

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
This research project will be collecting blood samples and/or buccal swabs. Patients will also be given the option to consent for lymph node and bone marrow slides collected for the registry that are determined to be unnecessary for the registry to be used for research studies, such as genomic sequencing or immunohistochemistry.

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:   No
Sampling Method:   Non-Probability Sample
Study Population
idiopathic Multicentric Castleman Disease patients worldwide

Inclusion Criteria:

- Person of any age with HHV8-negative, idiopathic multicentric Castleman disease, who have negative staining for LANA-1 on lymph node biopsy

Exclusion Criteria:

  • Patients without a pathology report that indicates Castleman Disease

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 identifier (NCT number): NCT02853968

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Contact: David C Fajgenbaum, MD, MBA, MSc 215-614-0936
Contact: Dustin Shilling, PhD

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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David Fajgenbaum, MD, MBA, MSc    215-614-0936   
Contact: Dustin Shilling, PhD    215-614-0936   
Sponsors and Collaborators
University of Pennsylvania
Castleman Disease Collaborative Network
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Principal Investigator: Vera Krymskaya, PhD, MBA University of Pennsylvania

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: University of Pennsylvania Identifier: NCT02853968     History of Changes
Other Study ID Numbers: 823546
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
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.
Keywords provided by University of Pennsylvania:
Unlock the Cell
Castleman's Disease
Castleman Disease
Angiofollicular Lymph Hyperplasia
multicentric Castleman's disease
multicentric Castleman disease
idiopathic multicentric Castleman disease
Additional relevant MeSH terms:
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Castleman Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases