NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm (NET-TIME)

Inflammatory Tumor Microenvironment in Pituitary Neoplasm

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.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Tumor

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Sabrina Chiloiro; Phone Number: +390630154440; Email: sabrina.chiloiro@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA
      • Principal Investigator: Sabrina Chiloiro
      • Contact: Sabrina Chiloiro; Phone Number: +390630154440; Email: sabrina.chiloiro@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with pituitary adenomas

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chemokines in PitNETS samples	Identify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997	24 months
Chemokines in PitNETS samples	Quantify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997	24 months
pituitary antibodies in PitNET	Quantify plasma pituitary antibodies associated with the various subtypes of PitNET under study	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.	24 months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Sabrina Chiloiro, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Pituitary Diseases; Pituitary Neoplasms
• Other Study ID Numbers: 5116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No