ACCELERATE
Research type
Research Study
Full title
ACCELERATE: AN INTERNATIONAL, OBSERVATIONAL REGISTRY FOR PATIENTS WITH CASTLEMAN DISEASE
IRAS ID
214373
Contact name
Matthew Streetly
Contact email
Sponsor organisation
Hospital of the University of Pennsylvania
Clinicaltrials.gov Identifier
231409, PAREXEL project No:
Duration of Study in the UK
4 years, 10 months, 31 days
Research summary
The ACCELERATE study is an international, observational, open-ended registry for patients with Castleman disease. Primary study objectives are to collect real-world demographic, clinical, laboratory, Patient Reported Outcome (PRO), and treatment data on patients with Castleman disease. Secondary objectives include carefully defining clinical features and biomarkers associated with Castleman disease to inform diagnostic criteria and identify subgroups of patients, inventory Castleman disease treatments and assess their clinical effectiveness and safety profiles, to collect data on survival of Castleman disease patients and quality of life metrics and inventory the types and locations of clinical tissue samples that may be available for future research. Results will be presented descriptively and there is no formal hypothesis.
The registry will recruit patients given a diagnosis of Castleman disease regardless of the date of diagnosis and will allow entry for patients with both unicentric and multicentric variants. Patients will be eligible for entry regardless of HHV8 / HIV status. Patient study entry is via a "Patient-powered arm" (PPA) and a "Physician-directed arm" (PDA). The "Patient-powered arm" (PPA) is for patient self-enrollment but applies only to patients outside of the UK and European Union. UK patients will be entered into the study via the "Physician Directed Arm”
"Physician-directed arm" (PDA). The study will run at 10 study sites in the EU. The Participating Physicians and site staff at these sites will consent and enroll patients and perform data entry in English. Additional data may also be collected through physician and patient surveys. Participating Physicians may enter deceased patients into the registry, as per local regulation. The Accelerate Registry Team (ART; Univ of Penn) will serve as the Global Data Coordinating Centre for all data collected through the PPA and the PDA. The ART will be responsible for the Statistical analysis, data collection and monitoring as well as for safety, reporting, and managing data access and transfer.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0178
Date of REC Opinion
8 May 2017
REC opinion
Favourable Opinion