PituitaryDataPitNCT05601141
Clinics and Epidemiology of Pituitary Diseases in Modena Area Population
An observational study of Pituitary, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 24 Oct 2022to 24 Oct 2031
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Who may be able to join
- subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Who cannot join
- subjects under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Modena, Modena, 41126
Vincenzo Rochira, Professor, +390593962453, vincenzo.rochira@unimore.it
Chiara Diazzi, PhD, +390593961816, chiaradiazzi@gmail.com
About this study
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)
This is an observational, longitudinal, single-center study.
The study is divided in two phases:
Read more
- 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.
- Conditions
- Pituitary
- Medical subject headings
- Pituitary Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start24 Oct 2022
- Primary completion24 Oct 2031 (estimated)
- Study completion24 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PituitaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Rochira, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601141
- Sponsor's protocol ID
- 289/2021
- Acronym
- DataPit
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 21474686Molitch 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 23040742Vasilev 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 27068689Buurman 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 16645024Tresoldi 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 31525736Mai 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05601141
- Acronym / sponsor ID
- DataPit / 289/2021
- Conditions
- Pituitary
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 24 Oct 2031 (estimated)
- Study completion
- 24 Oct 2031 (estimated)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Key inclusion criteria (1 listed)
- subjects affected by pituitary disorders who attended Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Key exclusion criteria (1 listed)
- subjects under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of pituitary patients
Time frame: 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.
1 secondary outcome
Management of pituitary patients
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 21474686Freda 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.
- Background: PubMed 23040742Molitch 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.
- Background: PubMed 27068689Vasilev 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.
- Background: PubMed 16645024Buurman 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.
- Background: PubMed 31525736Tresoldi 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.
- Background: PubMed 33724917Mai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Unit of Endocrinology of Azienza Ospedaliero-Universitaria di Modena
Modena, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of pituitary patients (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05601141, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.