International Registry for Patients With Castleman Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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 1000 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 anywhere in the United States of America (USA), Canada, or rest of world will be able to enroll themselves directly into the registry. Participants 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.

Official Title
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ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Castleman Disease

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

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common Symptoms | 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. | 5 years | 
| Common Laboratory Abnormalities | 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. | 5 years | 
| Treatment | 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. | 5 years | 
| Survival | 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. | 5 years | 
| Identify patient subtypes | We will use data collected through this study to identify patient subgroups, particularly those that are not responsive to current treatments | 4 years | 
| Identify clinical outcome measures | We will use data collected through this study to determine the optimal parameters for overarching clinical outcome measures for use in future trials | 4 years | 
| Identify clinical biomarkers | We will use data collected through this study to identify biomarkers of treatment response | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient registry, ACCELERATE study, CD, MCD, iMCD, Castleman, Castleman's Disease, Angiofollicular Lymph Hyperplasia, multicentric Castleman's disease, multicentric Castleman disease