ASPIrin use and colorectal CANcer risk (ASPICAN)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ACETYLSALICYLIC ACID
• Medical condition to be studied:
  Colorectal cancer

Population studied

• Short description of the study population:
  Patients with a first hospitalization for cardiovascular disease (CVD) during the period 2005-2010.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Colorectal cancer patients
• Estimated number of subjects:
  35000

Study design details

• Main study objective:
  The aim of this study is to investigate the association between LDA use and the risk of developing CRC in patients in secondary cardiovascular prevention.
• Outcomes:
  New onset of colorectal cancer
• Data analysis plan:
  Use of LDA in the study cohort will be described during the first 5 years from cohort entry according to the exposure categories defined above. Characteristics of the full study cohort will be described at cohort entry and at start of at risk period.The incidence rate of CRC will be calculated using the number of observed cases as the numerator and the total amount of person-time cumulated during the “period at risk” (i.e. after the fifth year from cohort entry) as the denominator, stratified by sex and age group. Multivariable conditional regression will applied to estimate odds ratio and 95% confidence intervals for the association between LDA use and CRC.