Clinics and Epidemiology of Pituitary Diseases in Modena Area Population

Pituitary Clinical Trial

— DataPit  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05601141
• Other study ID #: 289/2021
• Status: Active, not recruiting
• Start date: October 24, 2022
• Est. completion date: October 24, 2031

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: October 24, 2031
• Est. primary completion date: October 24, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pituitary
• Pituitary Diseases

Locations

Country	Name	City	State
Italy	Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 years