DARWIN EU® - Characterisation of systemic treatments for the management of ovarian cancer

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Ovarian epithelial cancer

Population studied

• Short description of the study population:
  For all study objectives, the inclusion criteria include: ; • Individuals with a first diagnosis of ovarian cancer during the study period, up to one year prior to end of data availability. ; • Females aged ≥18 years at the date of diagnosis. ; No prior history requirement has been established for this study, in accordance with how patient’s observability is defined in the included data sources (see Section 8.4). We will include cases up to one year prior to the end of data availability to ensure some follow-up time for capturing treatments (e.g., if data are available through December 2024, cases will be included up to December 2023). ; EOC will be defined using a range of EOC types, consisting of several histological subtypes (such as, high-grade and low-grade serous cancers and (aetiologically and genetically distant) endometrioid, clear-cell and mucinous cancers) and stages. ; This also includes cancers that arise in the fallopian tube as well as the histologically similar primary peritoneal cancers. Systematised Nomenclature of Medicine (SNOMED) and International Classification of Diseases for Oncology, Third Edition (ICD-O-3) codes will be used to identify ovarian cancer cases. ; A preliminary concept set for the identification of ovarian cancer specific to ovaries is described in Annex IV. ; These codes will be refined during the study execution following the DARWIN EU® phenotyping standard processes, which involve the review of code lists by clinical experts, and the review of phenotypes after their execution in the participating data sources.
• Age groups:
  • 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:
  A cohort study, describing characteristics of females with newly diagnosed ovarian cancer (objective 1), assessing the number of individuals treated by ingredient and treatment class (objective 2), as well to analyse treatment sequences and combinations (objective 3).
• Main study objective:
  1. To describe demographic and pre-specified characteristics of patients newly diagnosed with epithelial ovarian cancer, overall and by age.; 2. To describe the number of patients treated with systemic treatments, by ingredient and treatment class (i.e., alkylating agents, anthracyclines, antimetabolites, DNA agents, platinum-based chemotherapy, taxanes, topoisomerase inhibitors, vinca alkaloid, PARP inhibitors, monoclonal antibodies, hormonal agents), overall and by age and calendar year, and where possible, cancer stage.; 3. To describe sequences of treatments and treatment combinations for ovarian cancer, overall and stratified by age, and where possible, cancer stage.