Translating basic science into improved patient outcomes in ovarian cancer: an Ireland-UK collaboration investigating common pharmacological exposures and tumour characteristics, recurrence, survival and mortality (Effects of Pharmacological exp. on Ovarian Cancer)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Ovarian cancer

Population studied

• 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)
• Estimated number of subjects:
  2960

Study design details

• Main study objective:
  The principal study objective is to investigate the association between commonly prescribed medications and cancer-specific survival in the ovarian population.
• Outcomes:
  The primary outcome of the study will be cancer specific mortality. It will be evaluated for association with use of statins, β-blockers, NSAIDs pre-diagnosis to ovarian cancer. Secondary outcomes for this study will be to assess the medication effects on all-cause mortality, cancer recurrence and the odds of distant disease at the time of diagnosis.
• Data analysis plan:
  The statistical analysis for all three population cohorts (Ireland, Northern Ireland, United Kingdom) will performed separately and estimates combined using a prospective meta-analysis approach. The analysis will compare exposed versus unexposed, with exposure defined at the time of diagnosis (i.e. pre-diagnosis exposure). In each cohort, stage at diagnosis cases (Stage N1 or M1) will be compared to controls (matched on age, year of diagnosis) using conditional logistic regression to estimate odds ratios (OR) and 95% confidence intervals for exposure to each drug class. Cox proportional hazards models will be used to compute unadjusted and adjusted hazard ratios for other outcomes. Secondary analysis will consider exposure (including post-diagnostic period) as a time-varying dichotomous (ever/never) covariate. Exposure will be lagged by 6 months.