Riesgo de cáncer colorrectal asociado al uso de medicamentos: estudio de casos y controles (IJG-CCR-2015)

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Colorectal 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:
  30000

Study design details

• Main study objective:
  To assess the association between CRC and chronic exposure to different pharmacological groups and active principles
• Outcomes:
  demographic and anthropometric characteristics (age, sex, geographic distribution, MEDEA index, physical activity and BMI), toxic habits (smoking, alcohol), medical history (diabetes mellitus, inflammatory bowel disease, polyps of the colon and rectum, adenomatous colon polyps, intestinal malabsorption, cardiovascular disease, cerebrovascular or peripheral vascular disease, etc.), Charlson index, frequenting primary care (number of visits in the last year) and the number of prescriptions (active on index date), laboratory parameters (hemoglobin, hematocrit, leukocytes, liver and lipid profile, glycemia and glycated hemoglobin, glomerular filtration rate last predetermination to the index date), and drug exposure
• Data analysis plan:
  We will analyze CRC risk associated with chronic exposure to drugs adjusted by risk factors (age, sex, and other variables that are shown associated with the disease and possibly the exhibitions of the population) by logistic regression. We will analyze dose-response drugs associations showing statistical significance, in terms of duration of exposure and cumulative dose relationship. Possible drug interactions and potential effect modifiers exhibitions will be explored.Associations will be expressed as odds ratio estimates and confidence intervals of 95%.