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NCT Number: NCT07594262

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Sabrina Chiloiro

CONTACT

[email protected]

+390630154440

Sabrina Chiloiro

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cells immune systems

    Time frame: 24 months

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

Secondary outcomes

  1. Chemokines in PitNETS samples

    Time frame: 24 months

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

  2. Chemokines in PitNETS samples

    Time frame: 24 months

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

  3. pituitary antibodies in PitNET

    Time frame: 24 months

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

  4. Identify the biomarkers associated with the various PitNET subtypes, anatomical-pathological and morphological characteristics, surgical outcome and response to medical therapy in PitNET

    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, through statistical software R. We will use clinical parameters for the measurement.

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina Chiloiro

CONTACT

[email protected]

+390630154440

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Acronym: NET-TIME

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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