NCT06973824

Brief Summary

Pituitary tumors represent a heterogeneous group of neoplasms by histotype. The pituitary adenomas are the most frequent heteroformation, among those affecting the pituitary gland, followed by meningiomas, craniopharyngiomas, germosomes and tumours secondary, such as metastases and lymphomas. Since these conditions are considered rare, the data epidemiology and prognosis to predict the natural history of these diseases can not be considered conclusive. Pituitary adenomas are a useful model for epidemiology in the study of pathology pituitary. Over the past 20 years, several attempts have been made to identify unique prognostic factors, which predict the outcome of these pathologies, but without To arrive at a definitive classification. The purpose of this study aims to collect clinical, biochemical, morphological and pathological data on the retrospective and prospective cohort of over 1600 patients undergoing neurosurgical removal of pituitary tumors in the last 20 years, to develop a prognostic classification.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2025Apr 2028

First Submitted

Initial submission to the registry

January 22, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

January 22, 2025

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tumor recurrence

    Frequency of tumor recurrence at 24 months of follow-up

    From enrollement to last observation at 24 months of follow-up

Study Arms (1)

Patients with pituitary tumors

Patients with pituitary tumors, underwent surgical resection

Other: Frequency of disease recurrence

Interventions

To collect data of pituitary disease recurrence

Patients with pituitary tumors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older then 18 years with diagnosis of pituitary tumors (pituitary adenoma, pituitary neuroendocrine tumors, meningiomas, craniopharingiomas, germinoma, metastasis)

You may qualify if:

  • Patients underwent surgery for pituitary tumors;
  • pathology diagnosis of pituitary tumors;
  • patients older then 18 years at diagnosis of pituitary tumors;
  • years follow-up;

You may not qualify if:

  • age lower then 18 years
  • follow-up shorter than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, IT, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Pituitary NeoplasmsPituitary Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesEndocrine System Diseases

Study Officials

  • Francesco Doglietto, Prof

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2025

First Posted

May 15, 2025

Study Start

March 10, 2025

Primary Completion (Estimated)

February 15, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations