NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial population

Patients with pituitary adenomas

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

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