DARWIN EU® - Enhanced Preparedness of the DARWIN EU Network for regulatory questions in oncology – DARWIN OncoNet

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Method development or testing
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  The study population will include all individuals who meet the eligibility criteria at study entry.
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • 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)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  Cohort studies will be conducted using routinely collected health data from 18 data sources from 14 countries across Europe.
• Main study objective:
  o characterise and map oncology-related data into the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) for individuals with selected cancer types by:; 1.1. Characterising individuals with selected cancer types in terms of age at the time of diagnosis, sex, performance status, cancer stage, cancer grade, clinical and laboratory measurements, and cancer treatments and procedures before and after data mappings.; 1.2. Providing guidance and support in mapping data on tumour grade, stages (American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) Tumour, Node, Metastasis (TNM) classification), selected cancer treatments (treatment episodes, regimens, and information regarding cycles/sequencing), and biomarkers to the OMOP CDM.; 1.3. Developing and implementing phenotypes for the definition of cancer subtypes, grades, and stages (AJCC/UICC TNM), and cancer-specific measurements (tumour-specific biomarkers) at and after cancer diagnosis in individuals with selected cancer types.; To develop and evaluate algorithms to identify oncological treatment episodes, regimens, and lines of therapy, and to describe regimen level treatment patterns received by patients with selected cancers.; To identify available data elements to describe treatment response, cancer progression and recurrence, and relevant time-to-event endpoints.; To create a database with aggregate counts related to oncology to support future feasibility assessments in the DARWIN EU® Data Network.