Clinical Trial: International Registry for Patients With Castleman Disease
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Ca
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.
Detailed Summary:
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
Sponsor: University of Pennsylvania
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Pennsylvania
Dates:
Date Received: June 22, 2016
Date Started: October 2016
Date Completion: September 2021
Last Updated: October 21, 2016
Last Verified: October 2016
