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International Registry for Patients With Castleman Disease (ACCELERATE)

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: NCT02817997
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : August 28, 2019
Janssen Pharmaceuticals
Castleman Disease Collaborative Network
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The purpose of this study is to collect clinical, laboratory, and patient survey data from patients with Castleman disease to improve understanding, diagnosis, and treatment of the disease.

Condition or disease
Castleman Disease Castleman's Disease Giant Lymph Node Hyperplasia Angiofollicular Lymph Hyperplasia Angiofollicular Lymph Node Hyperplasia Angiofollicular Lymphoid Hyperplasia GLNH Hyperplasia, Giant Lymph Node Lymph Node Hyperplasia, Giant

Detailed Description:

This project is supported by the Castleman Disease Collaborative Network.

Visit the CDCN website at to sign up for the ACCELERATE registry!

The ACCELERATE patient registry will give patients and families the opportunity to contribute their medical data to improve understanding of Castleman Disease. The patient registry will obtain real-world demographic, clinical, laboratory, and patient reported outcomes, and treatment data from 500 patients worldwide with Castleman Disease.

This registry will help to provide important data for future Castleman Disease research studies. The patient registry helps centralize information on this rare disease, and provides researchers a way to obtain data on Castleman Disease patients. The major objectives for the registry include:

  1. Improve our understanding of the natural history (signs, symptoms, laboratory values, survival data, outcome predictors), pathogenesis, and treatment of Castleman disease by collecting a standardized set of demographic and longitudinal data from CD patients,
  2. Build capacity for collaboration between patients, providers, researchers, and industry by collecting clinical data and tracking the location of all available tissue samples for future studies ("virtual biorepository"), and
  3. Assemble "real-world" data related to burden of disease, treatments used, tolerability, and safety data.

Individuals affected by Castleman Disease and families of deceased patients are invited to join the registry. The patient registry will have two methods of entry. Patients located in the following countries (Germany, France, Italy, UK, or Spain) are recommended to contact the specific investigators at the sites listed below via the "physician-directed arm." Participating physicians will consent and enroll patients, enter their medical record data into the registry, and update medical records periodically.

Patients located anywhere in the United States of America (USA), Canada, or rest of world (except for patients in select countries in the EU listed below) will be able to enroll themselves directly into the registry via the "patient-powered arm." Participants in the patient-powered arm will enroll online and be asked to provide their electronic medical records to University of Pennsylvania researchers for data extraction. All patients in both groups will also be asked to complete questionnaires every three months about their symptoms, treatments, and experiences with Castleman Disease. Complete participant information will be stored in a secure database.

Researchers who are interested in studying Castleman Disease can also request access to registry datasets.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Castleman Disease
Study Start Date : October 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Primary Outcome Measures :
  1. Common Symptoms [ Time Frame: 6 months ]
    There is no intervention tested in this registry. We want determine what are common symptoms are associated with Castleman Disease. We will be examining the number of instances various symptoms such as fatigue, malaise, fever are recorded in the medical records.

  2. Common Laboratory Abnormalities [ Time Frame: 6 months ]
    There is no intervention tested in this registry. We want determine what are common laboratory abnormalities associated with Castleman Disease. We will be examining the values of specific laboratory values associated with Castleman's Disease such as C-Reactive Protein (CRP), ferritin, and hemoglobin recorded in the medical records.

  3. Treatment [ Time Frame: 6 months ]
    There is no intervention tested in this registry. We want determine what are common treatments used for patients with Castleman Disease. We will be examining the number of instances specific treatments such as steroids and chemotherapy are recorded in the medical records.

  4. Survival [ Time Frame: 6 months ]
    There is no intervention tested in this registry. Distribution of time-to-event variables will be estimated using standard survival analysis methods, including Kaplan-Meier product-limit survival curves. The median time to event with 2-sided 95% confidence intervals will be estimated.

Biospecimen Retention:   Samples With DNA
Lymph node and/or bone marrow slides and/or tissue blocks may be sent to research team at the University of Pennsylvania to be scanned and uploaded to assist with grading likelihood of accurate diagnosis, if allowed by local regulations. Patients will 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Castleman Disease patients worldwide

Inclusion Criteria:

  • Person of any age
  • Have a reference pathology report suggesting "Castleman disease" not limited to cutaneous involvement only that can be uploaded
  • Be able to provide electronic informed consent, as per local regulations
  • Deceased patients may also be enrolled when a reference pathology report suggesting "Castleman disease" can be supplied or when the ART is able to locate and upload such a pathology report.

Exclusion Criteria:

  • Because this registry is designed to provide as wide a picture of routine clinical practice as possible, inclusion criteria are set deliberately wide and there are no exclusion criteria.

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): NCT02817997

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

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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David C Fajgenbaum, MD, MBA, MSc    215-614-0936   
Contact: Dustin Shilling, PhD    215-614-0936   
Principal Investigator: David C Fajgenbaum, MD, MBA, MSc         
Hopital Cl Huriez Recruiting
Lille, Nord, France, 59037
Contact: Louis Terriou, MD    +33320444433   
Principal Investigator: Louis Terriou, MD         
Hopital Saint-Louis Recruiting
Paris, France, 75010
Contact: Eric Oksenhendler, MD    +33142499690   
Principal Investigator: Eric Oksenhendler, MD         
Universitätsklinikum Münster Recruiting
Munster, NRW, Germany, 48149
Contact: Linus Angenendt, MD    +492518347587   
Principal Investigator: Linus Angenendt, MD         
Infektionsmedizinisches Centrum Recruiting
Hamburg, Germany, 20095
Contact: Susanne Heesch    +494028407370   
Contact: Christian Hoffmann, MD, PhD    +494028004200   
Principal Investigator: Christian Hoffmann, MD, PhD         
University of Turin Recruiting
Torino, TO, Italy, 10125
Contact: Simone Ferrero, MD    +390116334220 ext 6884-4264   
Principal Investigator: Simone Ferrero, MD         
University of Bologna Recruiting
Bologna, Italy, 40138
Contact: Lisa Argnani, PhD    +390512143827   
Contact: Pier L Zinzani, MD, PhD    +390512144042   
Principal Investigator: Pier L Zinzani, MD, PhD         
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Alexander Fosså, MD, PhD    0047 22 934 000   
Contact: Marit Enoksen   
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Jose L Patier, MD    +34913368000 ext 8402   
Principal Investigator: Jose L Patier, MD         
United Kingdom
King's College Hospital (Oncology & Haematology Clinic) Recruiting
London, United Kingdom, SE1 9RT
Contact: Matthew Streetly, FRCPath, MD    +442032994607   
Contact: Steve Schey, MD    +442032994607   
Principal Investigator: Matthew Streetly, FRCPath, MD         
Sponsors and Collaborators
University of Pennsylvania
Janssen Pharmaceuticals
Castleman Disease Collaborative Network
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Principal Investigator: David C Fajgenbaum, MD, MBA, MSc University of Pennsylvania

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pennsylvania Identifier: NCT02817997    
Other Study ID Numbers: 10055241
824758 ( Other Identifier: University of Pennsylvania IRB )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified Researchers, who apply for access to the database 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. The Certification & Access Subcommittee will review applications from qualified researchers on an ongoing basis.
Keywords provided by University of Pennsylvania:
patient registry
Castleman's Disease
Angiofollicular Lymph Hyperplasia
multicentric Castleman's disease
multicentric Castleman disease
Additional relevant MeSH terms:
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Castleman Disease
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases