ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Castleman Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Treatment
研究概览
简要总结
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. Funding source - FDA OOPD.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment
时间窗: 5 years
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.
Identify clinical biomarkers
时间窗: 4 years
We will use data collected through this study to identify biomarkers of treatment response
Identify patient subtypes
时间窗: 4 years
We will use data collected through this study to identify patient subgroups, particularly those that are not responsive to current treatments
Identify clinical outcome measures
时间窗: 4 years
We will use data collected through this study to determine the optimal parameters for overarching clinical outcome measures for use in future trials
Common Symptoms
时间窗: 5 years
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.
Survival
时间窗: 5 years
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.
Common Laboratory Abnormalities
时间窗: 5 years
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.
次要结局
未报告次要终点