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Recruiting Observational

NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

NCT07594262 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-06-03
Last updated
2026-05-18

Condition(s) studied

Pituitary Tumor

Study summary

Over the past twenty years, a progressively increasing number of markers biochemical, clinical, imaging, histopathological or genetic have been suggested to attempt to predict aggression and therapeutic outcome, both in secretory PitNETs and in non-secretory PitNETs. In recent years, the microenvironment tumor (TEM) has been extensively studied in different malignancies, promoting the development of therapies target and immunotherapy with checkpoint inhibitors immune system (ICI). Data on TIME in PitNETs are scarce today and derive from studies conducted mainly on heterogeneous cases for type of PitNET. Therefore, the purpose of this research project is to investigate the TIME in PitNET, to identify immune biomarkers and new molecular pathways that can promote the use of ICI and target therapies in Aggressive PitNETs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria: * indication as per clinical practice and in agreement to current guidelines for surgical removal of the PitNET0; * patient naïve to medical therapy before surgical removal of PitNET; * Diagnosis of PitNET confirmed through the study pathological/histological; * over 18 years of age; * acceptance of participation in the study, by signing an informed consent. Exclusion Criteria: * History of medical therapy with analogs of somatostatin or dopamine agonist, previous the removal of the pituitary adenoma; * history of radiotherapy of the head and neck region earlier than 10 years after resection of the adenoma pituitary; * history of autoimmune diseases.

Primary outcome measure(s)

  • Cells immune systems — 24 months
    Quantify and locate cells immune systems (lymphocytes CD3, CD4, CD8, CD20, CD138, CD68+ macrophages) associated with the various PitNET subtypes in the study

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA Rome Lazio Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07594262 on ClinicalTrials.gov ↗ ← All trials in Italy