Clinical trial Recruiting at 1 site Observational Ages 18 to 100

Understanding the tumor’s immune environment in pituitary tumors

Official title: Inflammatory Tumor Microenvironment in Pituitary Neoplasm

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07594262 · Data updated 2026-11-12

This study tests how the tumor’s immune surroundings relate to pituitary tumors to help guide future treatments.

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment60 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionsimmunotherapy
Locations1 site (Rome, Lazio)
StatusRecruiting
StartedJune 3, 2023
Main results expectedSeptember 1, 2026
Study endsMarch 31, 2027
Registry record updatedMay 18, 2026
Trial IDNCT07594262 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (18+) with a diagnosed pituitary tumor who are planned for surgical removal and have not received prior medical therapy for the tumor.

Probably not a fit

Patients whose tumors do not display informative immune or molecular biomarkers may see no direct benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study examines the inflammatory and immune characteristics of pituitary tumors to identify biomarkers and molecular pathways that could guide immunotherapy and targeted therapies. Researchers will analyze tumor tissue and related data from adults undergoing surgical removal of pituitary tumors. The goal is to see how the tumor microenvironment correlates with aggressiveness and outcomes, without assigning an active treatment. No interventions are described; procedures follow standard surgical care and pathology assessment. Findings could inform future trials and biomarker-driven treatment decisions.

Why it matters

Potential benefit: If successful, the study could identify biomarkers that help predict aggressiveness and guide future therapy choices for pituitary tumor patients.

How similar studies have gone: Current TIME research in PitNETs is limited and heterogeneous, making this approach relatively novel but grounded in broader tumor immunology.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ENDOCRINOLOGIA
    Rome, Lazio, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.