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NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07594262
Acronym
NET-TIME
Enrollment
60
Registered
2026-05-18
Start date
2023-06-03
Completion date
2027-03-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Tumor

Brief 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.

Detailed description

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cells immune systems24 monthsQuantify and locate cells immune systems (lymphocytes CD3, CD4, CD8, CD20, CD138, CD68+ macrophages) associated with the various PitNET subtypes in the study

Secondary

MeasureTime frameDescription
Identify the biomarkers associated with the various PitNET subtypes, anatomical-pathological and morphological characteristics, surgical outcome and response to medical therapy in PitNET24 monthsIdentify 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.
Chemokines in PitNETS samples24 monthsIdentify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997
pituitary antibodies in PitNET24 monthsQuantify plasma pituitary antibodies associated with the various subtypes of PitNET under study

Countries

Italy

Contacts

CONTACTSabrina Chiloiro
sabrina.chiloiro@policlinicogemelli.it+390630154440
PRINCIPAL_INVESTIGATORSabrina Chiloiro

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026