NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

NCT07594262 | Recruiting

• 1 other identifier: 5116
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Chemokines in PitNETS samples

  24 months

• Chemokines in PitNETS samples

  24 months

• pituitary antibodies in PitNET

  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

  24 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pituitary adenomas

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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Sabrina Chiloiro

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina Chiloiro

CONTACT

+390630154440; sabrina.chiloiro@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: May 18, 2026
• Study Start: June 3, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IT (1)