International Registry for Patients With Castleman Disease (ACCELERATE)
|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
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|
- 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.
- 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.
- 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.
- 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
|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)|
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:
- 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,
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02817997
|Contact: David C Fajgenbaum, MD, MBA, MScfirstname.lastname@example.org|
|Contact: Dustin Shilling, PhDemail@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: David C Fajgenbaum, MD, MBA, MSc 215-614-0936 firstname.lastname@example.org|
|Contact: Dustin Shilling, PhD 215-614-0936 email@example.com|
|Principal Investigator: David C Fajgenbaum, MD, MBA, MSc|
|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 firstname.lastname@example.org|
|Principal Investigator: Eric Oksenhendler, MD|
|Universitätsklinikum Münster||Not yet recruiting|
|Munster, NRW, Germany, 48149|
|Contact: Linus Angenendt, MD +492518347587 email@example.com|
|Principal Investigator: Linus Angenendt, MD|
|Hamburg, Germany, 20095|
|Contact: Susanne Heesch +494028407370 firstname.lastname@example.org|
|Contact: Christian Hoffmann, MD, PhD +494028004200 email@example.com|
|Principal Investigator: Christian Hoffmann, MD, PhD|
|Humanitas Research Hospital||Not yet recruiting|
|Rozzano, Milano, Italy, 20089|
|Contact: Andrea Nozza, MD +390282244575 firstname.lastname@example.org|
|Contact: Barbara Ercoli +390282244568 email@example.com|
|Principal Investigator: Andrea Nozza, MD|
|University of Turin||Not yet recruiting|
|Torino, TO, Italy, 10125|
|Contact: Simone Ferrero, MD +390116334220 ext 6884-4264 firstname.lastname@example.org|
|Principal Investigator: Simone Ferrero, MD|
|University of Bologna||Not yet recruiting|
|Bologna, Italy, 40138|
|Contact: Lisa Argnani, PhD +390512143827 email@example.com|
|Contact: Pier L Zinzani, MD, PhD +390512144042 firstname.lastname@example.org|
|Principal Investigator: Pier L Zinzani, MD, PhD|
|Hospital Universitario Ramón y Cajal||Recruiting|
|Madrid, Spain, 28034|
|Contact: Jose L Patier, MD +34913368000 ext 8402 email@example.com|
|Principal Investigator: Jose L Patier, MD|
|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 firstname.lastname@example.org|
|Principal Investigator: Matthew Streetly, FRCPath, MD|
|Principal Investigator:||David C Fajgenbaum, MD, MBA, MSc||University of Pennsylvania|