Pituitary AdenomaTYEPDDNCT06973824
A Twenty-years' Experience in Pituitary Disease.
An observational study of Pituitary Adenoma and Pituitary Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Pituitary tumors represent a heterogeneous group of neoplasms by histotype. The pituitary adenomas are the most frequent heteroformation, among those affecting the pituitary gland, followed by meningiomas, craniopharyngiomas, germosomes and tumours secondary, such as metastases and lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Pituitary Cancer, Pituitary Disease
- What is being tested?
- Frequency of disease recurrence
- How many people
- 1,600 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2025to 30 Apr 2028
- 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 older then 18 years with diagnosis of pituitary tumors (pituitary adenoma, pituitary neuroendocrine tumors, meningiomas, craniopharingiomas, germinoma, metastasis)
Who may be able to join
- Patients underwent surgery for pituitary tumors;
- pathology diagnosis of pituitary tumors;
- patients older then 18 years at diagnosis of pituitary tumors;
- 2 years follow-up;
Who cannot join
- age lower then 18 years
- follow-up shorter than 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sabrina Chiloiro, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, IT, 00168
About this study
Official title: A Twenty-years' Experience in Pituitary Disease: Identification of Prognostic Factors in Pituitary Tumors
Pituitary tumors represent a heterogeneous group of neoplasms by histotype. The pituitary adenomas are the most frequent heteroformation, among those affecting the pituitary gland, followed by meningiomas, craniopharyngiomas, germosomes and tumours secondary, such as metastases and lymphomas. Since these conditions are considered rare, the data epidemiology and prognosis to predict the natural history of these diseases can not be considered conclusive. Pituitary adenomas are a useful model for epidemiology in the study of pathology pituitary. Over the past 20 years, several attempts have been made to identify unique prognostic factors, which predict the outcome of these pathologies, but without To arrive at a definitive classification. The purpose of this study aims to collect clinical, biochemical, morphological and pathological data on the retrospective and prospective cohort of over 1600 patients undergoing neurosurgical removal of pituitary tumors in the last 20 years, to develop a prognostic classification.
- Conditions
- Pituitary Adenoma, Pituitary Cancer, Pituitary Disease
- Being tested
- Frequency of disease recurrence
- Medical subject headings
- Pituitary Neoplasms, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequency of disease recurrenceOther
To collect data of pituitary disease recurrence
| Study group | Role | What they receive |
|---|---|---|
| Patients with pituitary tumors | Patients with pituitary tumors, underwent surgical resection Receives: Other: Frequency of disease recurrence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence
Frequency of tumor recurrence at 24 months of follow-up
Measured: From enrollement to last observation at 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start10 Mar 2025
- Primary completion15 Feb 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 1,600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doglietto Francesco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Francesco Doglietto, Prof, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973824
- Sponsor's protocol ID
- 6546
- Acronym
- TYEPDD
- Status last verified
- May 2025
- First submitted
- 22 Jan 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twenty-years' Experience in Pituitary Disease: Identification of Prognostic Factors in Pituitary Tumors
- ClinicalTrials.gov ID
- NCT06973824
- Acronym / sponsor ID
- TYEPDD / 6546
- Conditions
- Pituitary Adenoma, Pituitary Cancer, Pituitary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 15 May 2025 (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.
Pituitary tumors represent a heterogeneous group of neoplasms by histotype. The pituitary adenomas are the most frequent heteroformation, among those affecting the pituitary gland, followed by meningiomas, craniopharyngiomas, germosomes and tumours secondary, such as metastases and lymphomas. Since these conditions are considered rare, the data epidemiology and prognosis to predict the natural history of these diseases can not be considered conclusive. Pituitary adenomas are a useful model for epidemiology in the study of pathology pituitary. Over the past 20 years, several attempts have been made to identify unique prognostic factors, which predict the outcome of these pathologies, but without To arrive at a definitive classification. The purpose of this study aims to collect clinical, biochemical, morphological and pathological data on the retrospective and prospective cohort of over 1600 patients undergoing neurosurgical removal of pituitary tumors in the last 20 years, to develop a prognostic classification.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pituitary tumors | – | Other: Frequency of disease recurrencePatients with pituitary tumors, underwent surgical resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older then 18 years with diagnosis of pituitary tumors (pituitary adenoma, pituitary neuroendocrine tumors, meningiomas, craniopharingiomas, germinoma, metastasis)
Key inclusion criteria (4 listed)
- Patients underwent surgery for pituitary tumors;
- pathology diagnosis of pituitary tumors;
- patients older then 18 years at diagnosis of pituitary tumors;
- 2 years follow-up;
Key exclusion criteria (2 listed)
- age lower then 18 years
- follow-up shorter than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frequency of disease recurrenceTo collect data of pituitary disease recurrence | Other | Patients with pituitary tumors |
Primary outcome
Tumor recurrence
Time frame: From enrollement to last observation at 24 months of follow-up
Frequency of tumor recurrence at 24 months of follow-up
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 15 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Sabrina Chiloiro, MD contact
Francesco Doglietto, Prof principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Adenoma and Pituitary Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 inclusion and 2 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 15 May 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?
Contact Francesco Doglietto, Prof (+390630155701, francesco.doglietto@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence (time frame: From enrollement to last observation at 24 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.