An observational study in Pituitary Tumor, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
Pituitary adenomas are currently recognized such as pituitary neuroendocrine tumors (PitNETs), as originating from the neuroendocrine cells of the pituitary gland and represent about 10% of all intracranial tumors. 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, such as concentration blood tests of secreted hormones, the patient's gender, the age at onset of the disease, the size of the tumor, signs of local invasiveness, tumor indices of proliferation and mitotic indices. However, unique and reproducible markers of tumor aggressiveness and outcome have been identified therapeutic. 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. Plus most of the studies on TIME in PitNETs they were focused on study of the inflammatory cellular infiltrate and in particular on lymphocyte populations, showing a heterogeneous phenotype during the different phases of the natural history of neoplastic pathology. 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.
175 studies on the registry are indexed under Pituitary Neoplasms; 48 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 71 observational studies indexed under Pituitary Neoplasms.
Browse Pituitary Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Patients with pituitary adenomas
Exclusion Criteria:
Cells immune systems
Quantify and locate cells immune systems (lymphocytes CD3, CD4, CD8, CD20, CD138, CD68+ macrophages) associated with the various PitNET subtypes in the study
Time frame: 24 months
Chemokines in PitNETS samples
Identify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997
Time frame: 24 months
Chemokines in PitNETS samples
Quantify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997
Time frame: 24 months
pituitary antibodies in PitNET
Quantify plasma pituitary antibodies associated with the various subtypes of PitNET under study
Time frame: 24 months
Identify the biomarkers associated with the various PitNET subtypes, anatomical-pathological and morphological characteristics, surgical outcome and response to medical therapy in PitNET
Identify the biomarkers associated with the various PitNET subtypes, anatomical-pathological and morphological characteristics, surgical outcome and response to medical therapy, through statistical software R. We will use clinical parameters for the measurement.
Time frame: 24 months
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS