Pituitary TumorNET-TIMENCT07594262
NET-TIME: Inflammatory Tumor Microenvironment in Pituitary Neoplasm
An observational study of Pituitary Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pituitary Tumor
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pituitary adenomas
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA
Rome, Lazio, 00168
Sabrina Chiloiro, +390630154440, sabrina.chiloiro@policlinicogemelli.it
Sabrina Chiloiro
About this study
Official title: 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.
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.
- Conditions
- Pituitary Tumor
- Medical subject headings
- Pituitary Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (4)
Chemokines in PitNETS samples
Identify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997
Measured: 24 months
Chemokines in PitNETS samples
Quantify cytokines and chemokines in PitNETS samples, through Human Cytokine antibody Array ab 133997
Measured: 24 months
pituitary antibodies in PitNET
Quantify plasma pituitary antibodies associated with the various subtypes of PitNET under study
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start3 Jun 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina Chiloiro, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594262
- Sponsor's protocol ID
- 5116
- Acronym
- NET-TIME
- Status last verified
- May 2026
- First submitted
- 19 Sep 2024
- Last updated
- 18 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Tumor Microenvironment in Pituitary Neoplasm
- ClinicalTrials.gov ID
- NCT07594262
- Acronym / sponsor ID
- NET-TIME / 5116
- Conditions
- Pituitary Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pituitary adenomas
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Chemokines in PitNETS samples
Time frame: 24 months
Chemokines in PitNETS samples
Time frame: 24 months
pituitary antibodies 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 in PitNET
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Chiloiro principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Chiloiro (+390630154440, sabrina.chiloiro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cells immune systems (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.