ACCELERATE: AN INTERNATIONAL, OBSERVATIONAL REGISTRY FOR PATIENTS WITH CASTLEMAN DISEASE

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS14776
• Study ID:
  48792
• Official title and acronym:
  ACCELERATE: AN INTERNATIONAL, OBSERVATIONAL REGISTRY FOR PATIENTS WITH CASTLEMAN DISEASE
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Norway

  Spain

  United Kingdom
• Study description:
  The ACCELERATE patient registry will give Castleman Disease (CD) patients and families the opportunity to contribute their medical data to improve understanding of CD. The patient registry will obtain data from 500 patients worldwide with CD over a 5-year period. Main objectives: 1. Improve our understanding of the natural history, pathogenesis, and treatment of CD 2. Carefully define clinical features and biomarkers associated with CD to inform diagnostic criteria and identify subgroups of patients 3. Collect data on survival of Castleman disease patients and quality of life metrics 4. Build capacity for collaboration by collecting clinical data and tracking the location of all available tissue samples for future studies Patients of any age with CD and family members of deceased CD patients are invited to join the registry. The inclusion criteria requires that every patient have a pathology report mentioning or suggesting “Castleman disease” that is not limited to cutaneous involvement and that the patient or family member provide informed consent. Patients located in the following countries (Germany, France, Italy, UK, Spain) are recommended to contact the specific investigators at our 10 sites. Participating physicians will consent patients, enter medical record data into the registry, and update medical records periodically. Patients located anywhere outside of the 5 countries specified above will be able to directly enroll themselves at http://www.cdcn.org/accelerate and asked to provide their medical records to University of Pennsylvania for data extraction. All patients in both groups will be asked to complete questionnaires every three months about their symptoms, treatments, and experiences with CD. Complete participant information will be stored in a secure database. Every 6 months an interim analysis will be performed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hopital Cl Huriez Lille, France, Hopital Saint-Louis Paris, France, Infektionsmedizinisches Centrum Hamburg, Germany, Universitätsklinikum Münster Münster, Germany, King's College Hospital London, UK, Oslo universitetssykehus Oslo, Norway, Hospital Universitario Ramón y Cajal Madrid, Spain, University of Turin Torino, Italy, University of Bologna Bologna, Italy

Networks

Castleman Disease Collaborative Network

Study timelines

Date when funding contract was signed

Actual:10/02/2016

Study start date

Actual:29/12/2016

Data analysis start date

Planned:23/11/2018

Date of interim report, if expected

Planned:01/06/2019

Date of final study report

Planned:01/05/2023

Actual:01/05/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

EUSA Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)