Castleman DiseaseNCT02853968
Unlock the Cell: Castleman's Disease Flow Cytometry Study
An observational study of Castleman Disease and Angiofollicular Lymphoid Hyperplasia, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Castleman Disease, Angiofollicular Lymphoid Hyperplasia, GLNH
- What is being tested?
- Blood draw/buccal swab
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 30 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals of any age (including those younger than 7 years of age), gender and ethnicity who have been diagnosed with CD
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease
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
Read the 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.
- Conditions
- Castleman Disease, Angiofollicular Lymphoid Hyperplasia, GLNH, Hyperplasia, Castleman's Disease, Angiofollicular Lymph Hyperplasia
- Being tested
- Blood draw/buccal swab
- 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
- Medical subject headings
- Castleman Disease, Hyperplasia, Macular dystrophy, corneal type 1, Multi-centric Castleman's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw/buccal swabProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Castleman's Patients | Castleman's patients with HHV8 negative multicentric MCD Receives: 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 Receives: Procedure: Blood draw/buccal swab | |
| Healthy Donor Controls | Healthy subjects used for controls. These healthy subjects have no history of autoimmune disorders. Receives: Procedure: Blood draw/buccal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year ~
Secondary outcomes (2)
Use peripheral blood for biochemical testing
Biochemical testing will be performed on blood samples to collect inflammatory gene expressions using qPCR, ELISA and immunoblot.
Measured: 1 year ~
Extract DNA and RNA from tissue samples to store in biobank
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.
Measured: 1 year ~
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completion30 Jan 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castleman DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Castleman Disease Collaborative Network
- Responsible party
- Sponsor
- Investigators
- Vera Krymskaya, PhD, MBA, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853968
- Sponsor's protocol ID
- 823546
- Status last verified
- Mar 2020
- First submitted
- 15 Jul 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unlock the Cell: Intracellular Inflammatory Pathways and Flow Cytometry Study for Castleman's Disease
- ClinicalTrials.gov ID
- NCT02853968
- Acronym / sponsor ID
- 823546
- Conditions
- Castleman Disease, Angiofollicular Lymphoid Hyperplasia, GLNH, Hyperplasia, Castleman's Disease, Angiofollicular Lymph Hyperplasia
- Keywords
- Unlock the Cell, Castleman's Disease, CD, Castleman Disease, MCD, iMCD, Angiofollicular Lymph Hyperplasia, multicentric Castleman's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Castleman Disease Collaborative Network
- Study start
- Feb 2016 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Castleman's Patients | – | Procedure: Blood draw/buccal swabCastleman's patients with HHV8 negative multicentric MCD |
| Related Disease Controls | – | Procedure: Blood draw/buccal swabControls with inflammatory diseases similar to idiopathic multicentric Castleman's: i.e. HHV8+ MCD, HLH, Hodgkin disease |
| Healthy Donor Controls | – | Procedure: Blood draw/buccal swabHealthy subjects used for controls. These healthy subjects have no history of autoimmune disorders. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals of any age (including those younger than 7 years of age), gender and ethnicity who have been diagnosed with CD
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw/buccal swabThe 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. | Procedure or surgery | Castleman's Patients, Healthy Donor Controls, Related Disease Controls |
Primary outcome
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.
2 secondary outcomes
Use peripheral blood for biochemical testing
Time frame: 1 year ~
Extract DNA and RNA from tissue samples to store in biobank
Time frame: 1 year ~
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Unlock the Cell/Path to a Cure: Intracellular StudyLink provided by the sponsor.
- Hunt I: Columbia Hunt Pathogen StudyLink provided by the sponsor.
- Effectiveness of rituximab-containing treatment regimens in iMCDLink provided by the sponsor.
- iMCD International Treatment GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Castleman Disease
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
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Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease
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Phase II Study of Pacritinib in Kaposi Sarcoma Herpesvirus (KSHV)-Associated Multicentric Castleman Disease and KSHV-Associated Inflammatory Cytokine Syndrome (KICS)
KSHV Inflammatory Cytokine Syndrome (KICS), Kaposi Sarcoma Herpesvirus -Associated Multicentric Castleman Disease
RecruitingObservational study
Molecular Characterization of Viral-associated Tumors, Tumors Occurring in the Setting of HIV or Other Immune Disorders and Castleman Disease
Human Immunodeficiency Virus, Castleman's Disease
RecruitingObservational study
Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Krymskaya, PhD, MBA principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Castleman Disease and Angiofollicular Lymphoid Hyperplasia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect PBMCs to use for inflammatory cell profiling via FACS (time frame: 1 year ~). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.