Cell-lineage specific differences in presentation and outcomes of non-functioning pituitary adenomas – a multicentre study in patients seen at Endo-ERN reference centres

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients with non-functioning pituitary adenomas who are treated at an Endo-ERN Reference Center who received surgery and of whom pituitary tissue is available for the analysis of cell lineage-specific TF expression patterns (SF1+, TPIT+, PIT1+ or none) identified by immunohistochemistry.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)

Study design details

• Study design:
  For this study, data is collected both retrospectively and prospectively using the Core Registry and the Condition Specific Pituitary Tumour Module of the European Registries for Rare Endocrine Conditions (EuRRECa; Workpackage 5 of Endo-ERN).
• Main study objective:
  The primary aim is to evaluate the associations between TF expression identified by IHC and the radiological presentation, recurrence rates and therapeutic prognosis in patients with non-functioning pituitary adenomas treated at an Endo-ERN Reference Centre who received surgery, and of whom pituitary tissue is available for analysis of cell lineage-specific TF expression patterns using immunohistochemistry.
• Outcomes:
  Primary outcomes are the associations between exposure to the TF expression patterns (SF1+, TPIT+, PIT1+ or none) and outcomes:; • KNOSP score 3-4 (9) at time of first surgery; • Recurrence; • The number of interventions per 100 PY (pituitary surgery, radiation, medical treatment); • Time to radiation; • Time to second intervention ; in patients with non-functioning pituitary adenomas treated with surgery and seen at Endo-ERN Reference centers
• Data analysis plan:
  Descriptive data (n/N (%), mean ± SD, median (IQR)) will be analyzed depending on data structure and normality by Chi-square test or Fisher’s exact test, One way ANOVA (followed by post-hoc tests to identify differences between two specific groups), and Kruskal Wallis test (by post-hoc tests to identify differences between two specific groups).; ; Time-to-event data will be analyzed by Kaplan-Meier Survival Curves and Log-Rank tests, followed Simple Cox Regression analysis to assess the unadjusted HR per histopathological subtype in reference to SF1+ NFPAs.; The number of interventions will be standardized to the follow-up duration by dividing the number of interventions in a group by the sum of the individual follow-up times in years across all subjects in that group, multiplied by 100. Differences in the rate of interventions adjusted for the different follow-up times will be evaluated by calculating incidence rate ratios.