Unlock the Cell: Castleman's Disease Flow Cytometry Study

NCT02853968 | Completed DMC

• 1 other identifier: 823546
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• Collect PBMCs to use for inflammatory cell profiling via FACS

  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.

  1 year ~

• Collect PBMCs to use for cell culture experiments

  Peripheral blood will be collected to isolate peripheral blood mononuclear cells (PBMCs) for cell culture experiments.

  1 year ~

Secondary Outcomes (2)

• Use peripheral blood for biochemical testing

  1 year ~

• Extract DNA and RNA from tissue samples to store in biobank

  1 year ~

Study Arms (3)

Castleman's Patients

Castleman's patients with HHV8 negative multicentric MCD

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

Procedure: Blood draw/buccal swab

Healthy Donor Controls

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

Procedure: Blood draw/buccal swab

Interventions

Blood draw/buccal swab PROCEDURE

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.

Castleman's Patients; Healthy Donor Controls; Related Disease Controls

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Castleman Disease Collaborative Network: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• Hunt I: Columbia Hunt Pathogen Study
• Effectiveness of rituximab-containing treatment regimens in iMCD
• iMCD International Treatment Guidelines

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.

MeSH Terms

Conditions

Castleman Disease; Hyperplasia; Macular dystrophy, corneal type 1; Multi-centric Castleman's Disease

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vera Krymskaya, PhD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 3, 2016
• Study Start: February 1, 2016
• Primary Completion: January 30, 2019
• Study Completion: March 30, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)