International Study of Incident Cancer- Breast Cancer (ISICA)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A10A) INSULINS AND ANALOGUES

  INSULINS AND ANALOGUES
• Medical condition to be studied:
  Breast cancer

  Diabetes mellitus

Population studied

• Short description of the study population:
  Female, 18 years-old or more, without previous history of breast cancer
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Diabetes mellitus patients
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  the ISICA study aims mainly to assessthe association of breast cancer withthe use of individual insulins such asthe analogues glargine, lispro, andaspart, and human insulin formulationssuch as isophane and regularhuman insulin, compared with noninsulinuse in patients with diabetes.
• Outcomes:
  It is a case control study. Cases are breast cancer patients with diabetes.
• Data analysis plan:
  Exposures to insulin considered in the multivariate model will be categorised as:- Groups of insulin:a) Glargine useb) Aspart Insulin usec) Lispro insulin use d) Human Insulin usee) Other Insulin usef) No insulin use - Type of insulin use will be controlled for in relevant models:- Prandial use of insulin (yes/no)Odds ratios for each group of insulins will be estimated using the group “no insulin use” as the reference group. Comparisons between each group of insulin will be conducted. In particular, glargine insulin use will be compared with ‘non glargine insulins’ use ((b) to e)).