Invasiveness, NeoplasmNCT06247709
KLHL14 Expression as Predicting Factor of Invasiveness in pitNET
An observational study of Invasiveness, Neoplasm, run by Federico II University at 1 site in Italy.
Trial summary
OBJECTIVE: The objective of this study is to evaluate the correlation between KLHL14 expression and its cytoplasm-nuclear localisation and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Invasiveness, Neoplasm
- What is being tested?
- Immunohistochemical expression in pitNET cells of KLHL14
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 12 Mar 2023to 17 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Adult, Older adult
Study population: All consecutive cases of radiologically invasive pitNET undergoing tumor removal
Who may be able to join
- Adult men or women (age 18-70)
- Patients affected by nonfunctioning pituitary adenomas.
Who cannot join
- Prisoners
- Pregnant women
- Patient under 18 years
- Patients without capacity of discernment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of KLHL14 Expression as a Prognostic Factor of PitNET Invasiveness
OBJECTIVE: The objective of this study is to evaluate the correlation between KLHL14 expression and its cytoplasm-nuclear localisation and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions.
This is a multicenter and multidisciplinary study, with the involvement of the Departments of Neurosurgery of the University of Naples Federico II and the Department of Biosciences of the University of Teramo.
Read the detailed description
The investigators would like to analyse the possible correlations between the expression, the cytoplasm-nuclear localisation and the activity of the protein KLHL14 and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions. This study will be conducted on biological sample collected during surgery and primary cellular line derived from those samples.
Patients refer to neurosurgery for the detection of pituitary adenomas with various presenting symptoms that can be correlated to hormone production or to mass effect produced by the lesion on the optic apparatus or on the oculomotor nerves after invasion of the cavernous sinus. All patients undergo an ophthalmological clinical examination to define the presence of visual alteration and endocrinological assessment to determine eventual hormone hypersecretion. Finally, radiological exams, as magnetic resonance of the sellar region, are performed on patients to evaluate the extension of the pathology, its relationship to the surrounding neurovascular structures and therefore guide neurosurgical resection which is typically performed via an endoscopic endonasal transsphenoidal approach. Except for prolactin secreting pituitary adenomas, for which medical therapy with dopaminergic agonists is a viable approach, surgery with adenoma resection represent the gold standard for treatment.
- Conditions
- Invasiveness, Neoplasm
- Being tested
- Immunohistochemical expression in pitNET cells of KLHL14
- Medical subject headings
- Neoplasm Invasiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemical expression in pitNET cells of KLHL14Other
Lab essay evaluating the expression of KLHL 14
| Study group | Role | What they receive |
|---|---|---|
| Cases | All patients undergone surgery for the removal of a pituitary adenoma. Tissue samples of these cases were sent to biochemical essay to measure the expression and localisation of KLHL14. Receives: Other: Immunohistochemical expression in pitNET cells of KLHL14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasiveness degree
The expression of KLHL14 in invasive pituitary adenomas
Measured: Invasiveness degree will be determined at the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start12 Mar 2023
- Primary completion31 Oct 2023
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasiveness, NeoplasmStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Teramo
- Responsible party
- Principal investigator, Domenico Solari, Federico II University
- Investigators
- Barbara Barboni, PhD, Principal investigator, University of Teramo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247709
- Sponsor's protocol ID
- 17-1-j
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of KLHL14 Expression as a Prognostic Factor of PitNET Invasiveness
- ClinicalTrials.gov ID
- NCT06247709
- Acronym / sponsor ID
- 17-1-j
- Conditions
- Invasiveness, Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Teramo
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 8 Feb 2024 (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.
OBJECTIVE: The objective of this study is to evaluate the correlation between KLHL14 expression and its cytoplasm-nuclear localisation and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions.
This is a multicenter and multidisciplinary study, with the involvement of the Departments of Neurosurgery of the University of Naples Federico II and the Department of Biosciences of the University of Teramo.
Detailed description
The investigators would like to analyse the possible correlations between the expression, the cytoplasm-nuclear localisation and the activity of the protein KLHL14 and pituitary adenomas biological behaviour with particular focus on its role in epithelial mesenchymal transition and invasion of para and suprasellar regions. This study will be conducted on biological sample collected during surgery and primary cellular line derived from those samples.
Patients refer to neurosurgery for the detection of pituitary adenomas with various presenting symptoms that can be correlated to hormone production or to mass effect produced by the lesion on the optic apparatus or on the oculomotor nerves after invasion of the cavernous sinus. All patients undergo an ophthalmological clinical examination to define the presence of visual alteration and endocrinological assessment to determine eventual hormone hypersecretion. Finally, radiological exams, as magnetic resonance of the sellar region, are performed on patients to evaluate the extension of the pathology, its relationship to the surrounding neurovascular structures and therefore guide neurosurgical resection which is typically performed via an endoscopic endonasal transsphenoidal approach. Except for prolactin secreting pituitary adenomas, for which medical therapy with dopaminergic agonists is a viable approach, surgery with adenoma resection represent the gold standard for treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Immunohistochemical expression in pitNET cells of KLHL14All patients undergone surgery for the removal of a pituitary adenoma. Tissue samples of these cases were sent to biochemical essay to measure the expression and localisation of KLHL14. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive cases of radiologically invasive pitNET undergoing tumor removal
Key inclusion criteria (2 listed)
- Adult men or women (age 18-70)
- Patients affected by nonfunctioning pituitary adenomas.
Key exclusion criteria (4 listed)
- Prisoners
- Pregnant women
- Patient under 18 years
- Patients without capacity of discernment.
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 |
|---|---|---|
| Immunohistochemical expression in pitNET cells of KLHL14Lab essay evaluating the expression of KLHL 14 | Other | Cases |
Primary outcome
Invasiveness degree
Time frame: Invasiveness degree will be determined at the time of surgery
The expression of KLHL14 in invasive pituitary adenomas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Barbara Barboni, PhD principal investigator
University of Teramo
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 Invasiveness, Neoplasm, run by Federico II University 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasiveness degree (time frame: Invasiveness degree will be determined at the time of surgery). 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 8 Feb 2024.