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RecruitingNCT07594262NET-TIMEUpdated May 18, 2026

NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

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

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pituitary Tumor

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03

In context

Pituitary Neoplasms

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 →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with pituitary adenomas

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: 24 months

Secondary outcomes

  1. Chemokines in PitNETS samples

    Identify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997

    Time frame: 24 months

  2. Chemokines in PitNETS samples

    Quantify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997

    Time frame: 24 months

  3. pituitary antibodies in PitNET

    Quantify plasma pituitary antibodies associated with the various subtypes of PitNET under study

    Time frame: 24 months

  4. 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

07

Study locations

1 of 1 sites recruiting
  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA
    Rome, Lazio 00168, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07594262
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Jun 3, 2023
Primary completion
Sep 1, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
May 18, 2026

Study contacts

Sabrina Chiloiro
Contact
sabrina.chiloiro@policlinicogemelli.it
+390630154440
Sabrina Chiloiro
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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