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Recruiting NCT05601141

Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

— Observational Pituitary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pituitary. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pituitary Diseases in Modena Population: Clinical and Epidemiological Data Register of Pituitary Patients Attending the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena (DataPit)

Overview

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.

Primary outcome measures

  • Characterization of pituitary patients [Time frame: 10 years]
Secondary outcome measures (1)
  • Management of pituitary patients [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • subjects under 18 years old

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena — Modena

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33724917

Identifiers

NCT: NCT05601141 · 289/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗