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).

Sponsor
Azienda Ospedaliero-Universitaria di Modena (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05601141
Collaborator
(none)
1,500
1
108
13.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    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).
    Anticipated Study Start Date :
    Oct 24, 2022
    Anticipated Primary Completion Date :
    Oct 24, 2031
    Anticipated Study Completion Date :
    Oct 24, 2031

    Outcome Measures

    Primary Outcome Measures

    1. Characterization of pituitary patients [10 years]

      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.

    Secondary Outcome Measures

    1. Management of pituitary patients [10 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena Modena Italy 41126

    Sponsors and Collaborators

    • Azienda Ospedaliero-Universitaria di Modena

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Vincenzo Rochira, MD, PhD - Associate Professor of Endocrinology, Azienda Ospedaliero-Universitaria di Modena
    ClinicalTrials.gov Identifier:
    NCT05601141
    Other Study ID Numbers:
    • 289/2021
    First Posted:
    Nov 1, 2022
    Last Update Posted:
    Nov 1, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 1, 2022