DARWIN EU® - Cancer incidence during pregnancy

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• 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:
  Cancer cells present

Population studied

• Short description of the study population:
  All recorded pregnancy episodes of females aged 12 to 55 years at pregnancy start (i.e. index date) will be considered for inclusion.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 3 data sources from 3 countries across Europe and in 1 European Union (EU) member state.
• Main study objective:
  • A disease epidemiology study to address objective 1, assessing incidence of cancer occurring during pregnancy;; • A characterisation study to address objective 2, describing new primary cancers diagnosed during pregnancy.;
• Setting:
  This study will be conducted using routinely collected data from 3 data sources within the DARWIN EU® Data Network from 3 European countries.
• Outcomes:
  Objective 1:; Two outcomes will be used for this objective.; • Any cancer diagnosis. This will be any malignant cancer (excluding non-melanoma skin cancer), including new, relapsed, and recurrent disease.; • Diagnosis of a new cancer (excluding non-melanoma skin cancer). This will be a subset of the first, for which a washout period of 5 years will be used to exclude previous cancer cases (see Section 8.3).; Objective 2:; No outcome will be assessed as part of Objective 2.