To examine the impact of additional confounder adjustment for the potential association between second line T2DM therapy and thyroid cancer: a nested case-control study (GLP1i and thyroid cancer)

08/09/2023
13/12/2023
EU PAS number:
EUPAS106600
Study
Finalised
Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Other

If ‘other’, further details on the scope of the study

evaluation of counfounders impact
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(A10BJ) Glucagon-like peptide-1 (GLP-1) analogues
Glucagon-like peptide-1 (GLP-1) analogues

Medical condition to be studied

Thyroid 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

64000
Study design details

Main study objective

To calculate crude and adjusted effect estimates for GLP1-agonists and the association with thyroid cancer based upon the design for confounding adjustment in the study by Bezin et al. study. To determine the impact of additional adjustment for smoking status, BMI, and history of alcohol use/abuse on the effect estimates for GLP1-agonists (+/- other seco

Outcomes

Thyroid cancer

Data analysis plan

A cohort of diabetic patients will be created. From this, controls will be sampled through risk set sampling, matched for age, gender, cohort follow-up, and diabetes duration. The matching approach may be refined depending on the feasibility of identifying controls. Conditional logistic regression will be used to examine the association between each exposure and outcome. Odds ratios in this context can be considered akin to rate ratios.