Clinical trial NCT06247709: KLHL14 Expression as Predicting Factor of Invasiveness in pitNET
Official title: Evaluation of KLHL14 Expression as a Prognostic Factor of PitNET Invasiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasiveness, Neoplasm
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: University of Teramo
First posted: 2024-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive cases of radiologically invasive pitNET undergoing tumor removal

Brief 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.

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.

Eligibility criteria: INCLUSION CRITERIA:

* Adult men or women (age 18-70)
* Patients affected by nonfunctioning pituitary adenomas.

EXCLUSION CRITERIA:

* Prisoners
* Pregnant women
* Patient under 18 years
* Patients without capacity of discernment.

Primary outcomes:
measure: Invasiveness degree
timeFrame: Invasiveness degree will be determined at the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Federico II university
Study officials:
affiliation: University of Teramo
name: Barbara Barboni, PhD
role: PRINCIPAL_INVESTIGATOR
References: