ACCELERATE: International Registry for Patients With Castleman Disease

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT02817997

Collaborator

EUSA Pharma, Inc. (Industry), Castleman Disease Collaborative Network (Other)

500

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Other

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 :

Oct 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Outcome Measures

Primary Outcome Measures

Common Symptoms [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
2	Hopital Cl Huriez	Lille	Nord	France	59037
3	Hopital Saint-Louis	Paris		France	75010
4	Universitätsklinikum Münster	Munster	NRW	Germany	48149
5	Infektionsmedizinisches Centrum	Hamburg		Germany	20095
6	University of Turin	Torino	TO	Italy	10125
7	University of Bologna	Bologna		Italy	40138
8	Oslo University Hospital	Oslo		Norway	0424
9	Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
10	King's College Hospital (Oncology & Haematology Clinic)	London		United Kingdom	SE1 9RT