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 identification

• EU PAS number:
  EUPAS1000000489
• Study ID:
  1000000489
• Official title and acronym:
  Cell-lineage specific differences in presentation and outcomes of non-functioning pituitary adenomas – a multicentre study in patients seen at Endo-ERN reference centres
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  European Union

  Finland

  France

  Germany

  Greece

  Italy

  Netherlands

  Romania

  Spain

  Sweden
• Study description:
  In 2017, the evaluation of cell lineage-specific transcription factors (TFs) by immunohistochemistry (IHC) has; Study protocol been added to the World Health Organization (WHO) histopathological classification of pituitary neuroendocrine tumours (ENDO4) and this was maintained in the most recent WHO histopathological classification of 2022 (ENDO5). After the introduction of cell lineage-specific TFs into the histopathological classification, pituitary adenomas (PAs) that were negative for all anterior pituitary hormones could be classified into one of the three cell lineages based on positivity of cell lineage-specific TFs. As a results, non-functioning (NF) gonadotroph adenomas now include SF1+/H- NFPAs besides the previously identified LH+/FSH+ NFPAs, non-functioning corticotroph adenomas are expanded with TPIT+/H+ adenomas, and adenomas differentiating into the PIT1 cell lineage include PIT1+/H- adenomas. The radiological presentation and clinical prognosis of these newly defined histopathological subtypes have not been studied widely. A recent systematic review and meta-analysis (van der Hoeven et al. (2025)) concluded that there are indeed differences in radiological presentation at time of surgery, where cavernous sinus invasion was more prevalent in TPIT+ NFPAs and NCAs compared with SF1+ NFPAs and in NCAs compared with PIT1 NFPAs. The authors of this review also concluded that data on differences in recurrence rates and the use of postoperative radiotherapy is lacking. The primary aim is to evaluate the associations between TF expression identified by IHC (exposure) and the radiological presentation, recurrence rates and therapeutic prognosis (outcome) in patients with non-functioning pituitary adenomas treated at an Endo-ERN Reference Centre.
• Study status:
  Planned

Research institutions and networks

Institutions

Amsterdam UMC

Networks

European Reference Network on Rare Endocrine Conditions (Endo-ERN)

Study timelines

Date when funding contract was signed

Planned:01/10/2023

Study start date

Planned:14/10/2024

Date of final study report

Planned:01/03/2027

Sources of funding

EU institutional research programme

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable