NCT05601141

Brief Summary

This is an observational, longitudinal, single-center study. The study is divided in two phases:

  • FIRST PHASE (retrospective): registration of all patients affected by pituitary disorders followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena
  • SECOND PHASE (prospective): enrollment of all patients affected by pituitary disorders who attend the Unit of Endocrinology of the Azienda Ospedaliero-Universitaria of Modena. An anonymized database will be created to collect the data of the patients. In particular, the data collected for each patient will include: personal data, data relating to pituitary pathology, symptoms at diagnosis, physical examination, radiological imaging, visual field data, data on surgical intervention, data on histological examination, biohumoral examinations, hormone tests, densitometric data, data on replacement therapies, medical therapies or other pharmacological therapies, data on comorbidities.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Oct 2022

Longer than P75 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 Progress39%
Oct 2022Oct 2031

First Submitted

Initial submission to the registry

October 24, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2031

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

9 years

First QC Date

October 24, 2022

Last Update Submit

March 12, 2025

Conditions

Pituitary

Outcome Measures

Primary Outcomes (1)

  • Characterization of pituitary patients

    The primary aim of the study is to characterize subjects with pituitary disease by collecting anamnestic, clinical, biohumoral, radiological data, and data related to the treatment approach, in terms of surgery, medical therapies and/or hormone replacement therapies.

    10 years

Secondary Outcomes (1)

  • Management of pituitary patients

    10 years

Eligibility Criteria

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

Patients affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena

You may qualify if:

  • subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena

You may not qualify if:

  • subjects under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena

Modena, Modena, 41126, Italy

RECRUITING

Related Publications (6)

  • Freda PU, Beckers AM, Katznelson L, Molitch ME, Montori VM, Post KD, Vance ML; Endocrine Society. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011 Apr;96(4):894-904. doi: 10.1210/jc.2010-1048.

    PMID: 21474686BACKGROUND

  • Molitch ME. Management of incidentally found nonfunctional pituitary tumors. Neurosurg Clin N Am. 2012 Oct;23(4):543-53. doi: 10.1016/j.nec.2012.06.003. Epub 2012 Jul 31.

    PMID: 23040742BACKGROUND

  • Vasilev V, Rostomyan L, Daly AF, Potorac I, Zacharieva S, Bonneville JF, Beckers A. MANAGEMENT OF ENDOCRINE DISEASE: Pituitary 'incidentaloma': neuroradiological assessment and differential diagnosis. Eur J Endocrinol. 2016 Oct;175(4):R171-84. doi: 10.1530/EJE-15-1272. Epub 2016 Apr 11.

    PMID: 27068689BACKGROUND

  • Buurman H, Saeger W. Subclinical adenomas in postmortem pituitaries: classification and correlations to clinical data. Eur J Endocrinol. 2006 May;154(5):753-8. doi: 10.1530/eje.1.02107.

    PMID: 16645024BACKGROUND

  • Tresoldi AS, Carosi G, Betella N, Del Sindaco G, Indirli R, Ferrante E, Sala E, Giavoli C, Morenghi E, Locatelli M, Milani D, Mazziotti G, Spada A, Arosio M, Mantovani G, Lania AGA. Clinically Nonfunctioning Pituitary Incidentalomas: Characteristics and Natural History. Neuroendocrinology. 2020;110(7-8):595-603. doi: 10.1159/000503256. Epub 2019 Sep 13.

    PMID: 31525736BACKGROUND

  • Mai K, Fassnacht M, Fuhrer-Sakel D, Honegger JB, Weber MM, Kroiss M. The Diagnosis and Management of Endocrine Side Effects of Immune Checkpoint Inhibitors. Dtsch Arztebl Int. 2021 Jun 11;118(Forthcoming):389-96. doi: 10.3238/arztebl.m2021.0143. Online ahead of print.

    PMID: 33724917BACKGROUND

MeSH Terms

Conditions

Pituitary Diseases

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD - Associate Professor of Endocrinology

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 1, 2022

Study Start

October 24, 2022

Primary Completion (Estimated)

October 24, 2031

Study Completion (Estimated)

October 24, 2031

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

IT(1)