The Clinical Usefulness of the PANOMEN 3 Grade Score

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Clinical utility of proposed PANOMEN 3 grade score
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients with any type of pituitary adenomas (functioning and non-functioning) seen and/or treated at Endo-ERN Reference Centers.
• 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 clinical usefulness of the PANOMEN 3 Grade score in patients with all types of pituitary adenomas seen at Endo-ERN Reference Centers.
• Setting:
  (1) Patients seen and/or treated at Endo-ERN Reference Centers who are registered in the Core Registry and Pituitary Tumour Module (no age restriction);; (2) With the Primary Condition of Pituitary Adenoma (Index 1.23; 7.1) (Includes the following Specific Diagnosis: Pituitary adenoma, Cushing disease, Familial isolated pituitary adenoma, Functioning gonadotropic adenoma, Functioning pituitary adenoma, Mixed functioning pituitary adenoma, Non-functioning pituitary adenoma, Null pituitary adenoma, Prolactinoma, Silent pituitary adenoma, Somatomammotropinoma, TSH-secreting pituitary adenoma, Acromegaly, X-linked acrogigantism, Pituitary carcinoma; (3) Who received their diagnosis after 01-01-2015 (Index 1.22)
• Outcomes:
  Primary outcomes are the associations between the Grade scores at the time of diagnosis and at six months after a potential first surgery and tumour specific and general (co)morbidities, and HRs of Grade 1, 2, and 3 at time of diagnosis and six months after a potential first surgery in reference to Grade 0 for the following tumour specific (co)morbidities:; • Tumour growth/regrowth (event); • Biochemical remission (in patients with functioning pituitary adenomas) (event); • Biochemical recurrence (in patients with functioning pituitary adenoma in remission) (event); • First surgery (event); • Second surgery (in patients who have received a first surgery) (event); • Medical therapy (event); • Radiotherapy (event); • Clinical apoplexy (event); • Radiological apoplexy (event)
• Data analysis plan:
  Descriptive data (n/N (%), mean ± SD, median (IQR)) will be analyzed, dependent 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).; ; Potential differences in prevalences of comorbidities at the time of the calculated PANOMEN 3 Grade scores will be evaluated by Chi-square tests and by calculating odds ratios (ORs) via logistic regression analysis.; ; Time-to-event data will be analyzed by Kaplan-Meier Survival Curves and Log-Rank tests, followed by Simple Cox Regression analysis to assess the unadjusted HR per Grade in reference to Grade 0.