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Trial record 2 of 1462 for:    ACCELERATE

International Registry for Patients With Castleman Disease (ACCELERATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Pennsylvania
Sponsor:
Collaborators:
Janssen Pharmaceuticals
Castleman Disease Collaborative Network
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02817997
First received: June 22, 2016
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
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
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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Common Symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Common Laboratory Abnormalities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 500
Study Start Date: October 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Detailed Description:

This project is supported by the Castleman Disease Collaborative Network.

Visit the CDCN website at http://www.cdcn.org/accelerate 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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Castleman Disease patients worldwide
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817997

Contacts
Contact: David C Fajgenbaum, MD, MBA, MSc 215-614-0936 davidfa@mail.med.upenn.edu
Contact: Amy Y Liu, BA, BS 215-614-0689 amy.liu3@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: David C Fajgenbaum, MD, MBA, MSc    215-614-0936    davidfa@mail.med.upenn.edu   
Contact: Amy Y Liu, BA, BS    215-614-0689    amy.liu3@uphs.upenn.edu   
Principal Investigator: David C Fajgenbaum, MD, MBA, MSc         
France
Hopital Cl Huriez Not yet recruiting
Lille, Nord, France, 59037
Contact: Louis Terriou, MD    +33320444433    louis.terriou@CHRU-LILLE.fr   
Principal Investigator: Louis Terriou, MD         
Hopital Saint-Louis Not yet recruiting
Paris, France, 75010
Contact: Eric Oksenhendler, MD    +33142499690    eric.oksenhendler@sls.aphp.fr   
Principal Investigator: Eric Oksenhendler, MD         
Germany
Universitätsklinikum Münster Not yet recruiting
Munster, NRW, Germany, 48149
Contact: Linus Angenendt, MD    +492518347587    angenendt@uni-muenster.de   
Principal Investigator: Linus Angenendt, MD         
Infektionsmedizinisches Centrum Not yet recruiting
Hamburg, Germany, 20095
Contact: Susanne Heesch    +494028407370    mail@ich-studycenter.com   
Contact: Christian Hoffmann, MD, PhD    +494028004200    hoffmann@ich-hamburg.de   
Principal Investigator: Christian Hoffmann, MD, PhD         
Italy
Humanitas Research Hospital Not yet recruiting
Rozzano, Milano, Italy, 20089
Contact: Andrea Nozza, MD    +390282244575    andrea.nozza@humanitas.it   
Contact: Barbara Ercoli    +390282244568    barbara.ercoli@humanitas.it   
Principal Investigator: Andrea Nozza, MD         
University of Turin Not yet recruiting
Torino, TO, Italy, 10125
Contact: Simone Ferrero, MD    +390116334220 ext 6884-4264    simone.ferrero@unito.it   
Principal Investigator: Simone Ferrero, MD         
University of Bologna Not yet recruiting
Bologna, Italy, 40138
Contact: Lisa Argnani, PhD    +390512143827    lisa.argnani@unibo.it   
Contact: Pier L Zinzani, MD, PhD    +390512144042    pierluigi.zinzani@unibo.it   
Principal Investigator: Pier L Zinzani, MD, PhD         
Spain
Hospital Universitario Ramón y Cajal Not yet recruiting
Madrid, Spain, 28034
Contact: Jose L Patier, MD    +34913368000 ext 8402    joseluis.patier@salud.madrid.org   
Principal Investigator: Jose L Patier, MD         
United Kingdom
The Christie NHS Foundation Trust Not yet recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Contact: David Cotterell, MSc    +441619182309    David.Cotterell@christie.nhs.uk   
Contact: James Cavet, MBBS, PhD    +441614463272    Jim.cavet@christie.nhs.uk   
Principal Investigator: James Cavet, MBBS, PhD         
King's College Hospital (Oncology & Haematology Clinic) Not yet recruiting
London, United Kingdom, SE1 9RT
Contact: Matthew Streetly, FRCPath, MD    +442032994607    matthew.Streetly@gstt.nhs.uk   
Contact: Steve Schey, MD    +442032994607    sschey@nhs.net   
Principal Investigator: Matthew Streetly, FRCPath, MD         
Sponsors and Collaborators
University of Pennsylvania
Janssen Pharmaceuticals
Castleman Disease Collaborative Network
Investigators
Principal Investigator: David C Fajgenbaum, MD, MBA, MSc University of Pennsylvania
  More Information

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02817997     History of Changes
Other Study ID Numbers: 10055241  824758 
Study First Received: June 22, 2016
Last Updated: October 21, 2016
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee
Germany: Ethics Commission
France: Ethics Committee
Italy: Ethics Committee
United Kingdom: Research Ethics Committee
Spain: Ethics Committee
Individual Participant Data  
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
ACCELERATE study
CD
MCD
iMCD
Castleman
Castleman's Disease
Angiofollicular Lymph Hyperplasia
multicentric Castleman's disease
multicentric Castleman disease

Additional relevant MeSH terms:
Hyperplasia
Giant Lymph Node Hyperplasia
Lymphatic Diseases
Pathologic Processes
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2016