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RecruitingNCT05601141DataPitUpdated Mar 14, 2025

Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

An observational study in Pituitary, sponsored by Azienda Ospedaliero-Universitaria di Modena. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational

From the registry’s dates

  • Started Oct 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Pituitary Diseases with a site in Italy — 5 open to participants now, 5 under way, 1 of them phase 3. Pituitary Diseases · Italy.

Started
2022
the only one that year
Observational
5 of 10
3 open now
Registered
7th of 10
by date
Lead sponsor
1 of 10
Azienda Ospedaliero-Universitaria di Modena

Among the 10 studies in Pituitary Diseases with a site in Italy, this one is the only one that started in 2022, is one of 5 observational ones, and was the 7th registered.

Pituitary Diseases

74 studies on the registry are indexed under Pituitary Diseases; 15 are open to participants now.

Browse Pituitary Diseases studies →

Open to participants now

5 of the 10 studies in Pituitary Diseases with a site in Italy are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 12 Pituitary Diseases studies recruiting now, 6 (50%) set no upper age limit and 3 (25%) stop at 75 or younger; 3 take children under 18; 0 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Pituitary Diseases with a site in Italy, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pituitary

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • subjects under 18 years old
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

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.

    Time frame: 10 years

Secondary outcomes

  1. Management of pituitary patients

    The second aim is to integrate these data with current knowledge, in order to improve the clinical-diagnostic-therapeutic management of patients suffering from pituitary diseases, as well as to identify risk factors for the development of the disease.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 21474686 ↗
  • 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. PubMed 23040742 ↗
  • 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. PubMed 27068689 ↗
  • 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. PubMed 16645024 ↗
  • 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. PubMed 31525736 ↗
  • 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. PubMed 33724917 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2022 (actual). Primary completion is estimated for Oct 2031, 108 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 24, 2022
First posted
Nov 1, 2022
StartActual
Oct 24, 2022
Primary completionEst.
Oct 24, 2031
CompletionEst.
Oct 24, 2031
Last update
Mar 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05601141
Lead sponsor
Azienda Ospedaliero-Universitaria di Modena
Responsible party
Vincenzo Rochira (MD, PhD - Associate Professor of Endocrinology, Azienda Ospedaliero-Universitaria di Modena) — Principal investigator
First posted
Nov 1, 2022
Start date
Oct 24, 2022
Primary completion
Oct 24, 2031 (estimated)
Completion
Oct 24, 2031 (estimated)
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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