Unlock the Cell: Castleman's Disease Flow Cytometry Study

NCT ID: NCT02853968

Last Updated: 2020-03-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-03-30

Brief Summary

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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

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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.

Conditions

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Castleman Disease Angiofollicular Lymphoid Hyperplasia GLNH Hyperplasia Castleman's Disease Angiofollicular Lymph Hyperplasia Giant Lymph Node Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Castleman's Patients

Castleman's patients with HHV8 negative multicentric MCD

Blood draw/buccal swab

Intervention Type 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.

Related Disease Controls

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

Blood draw/buccal swab

Intervention Type 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.

Healthy Donor Controls

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

Blood draw/buccal swab

Intervention Type 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.

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Castleman Disease Collaborative Network

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/29732477

Effectiveness of rituximab-containing treatment regimens in iMCD

https://www.ncbi.nlm.nih.gov/pubmed/30181172

iMCD International Treatment Guidelines

Other Identifiers

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823546

Identifier Type: -

Identifier Source: org_study_id

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