NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Recruiting now

Conditions studied: Pituitary Tumor

In brief

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.

Key facts

Study ID

NCT07594262

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

60

Starts

2023-06-03

Expected to finish

2027-03-31

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA — Rome, Lazio, Italy (enrolling)

Full record on ClinicalTrials.gov

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