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

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational, multi-national, multicenter, prospective, natural history study

Study drug and medical condition

• Medical condition to be studied:
  Castleman's disease

Population studied

• Short description of the study population:
  The study population included patients of any age with Castleman disease from Germany, France, Italy, UK, Spain.; 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.
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women

  Other
• Special population of interest, other:
  Patients with Castleman disease
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Primary: •To collect real-world demographic, clinical, laboratory, Patient Reported Outcome (PRO), and treatment data on patients with Castleman disease. Secondary: Define clinical features/biomarkers associated with Castleman disease • Assess their effectiveness and safety profiles of Castleman disease treatment • Collect data on survival and quality of life metrics
• Data analysis plan:
  The statistical analysis plan for this registry aims to include analyses of demographics and baseline disease characteristics, treatment effectiveness data, patient reported outcome data, biologic parameters, safety data, and comparability between treatment groups.