CAncer Risk and INsulin analoGues (CARING) project

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Method development or testing

  Safety study (incl. comparative)

  Scoping review (including literature review)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

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

  Breast cancer

  Colorectal cancer

  Non-small cell lung cancer

  Bladder cancer

  Skin cancer

  Cervix carcinoma

  Non-Hodgkin's lymphoma

  Pancreatic carcinoma

  Hepatobiliary cancer

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  5000000

Study design details

• Main study objective:
  The primary aim of the study is to quantify the risk of cancer associated with the (long-term) use of insulin and insulin analogues by studying the effects of dosage, duration and/or intensity of insulin treatment on the likelihood of developing cancer and different types of cancer.
• Outcomes:
  - prostate cancer - breast cancer - colorectal cancer - lung cancer - bladder cancer - melanoma of skin - cancer of corpus uteri - non-Hodgkin lymphoma - pancreatic cancer - liver cancer, Any cancer, excluding non-melanoma skin cancer.
• Data analysis plan:
  We will perform a series of population-based cohort studies, using the Norwegian, Swedish, Danish and Finnish National Health Registries and the Clinical Practice Research Datalink (CPRD) from the United Kingdom. Studies will be performed in all databases separately, and multi-country data will be combined using several approaches.