KLHL14 Expression as Predicting Factor of Invasiveness in pitNET

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.

Study Overview

• Status: Completed
• Conditions: Invasiveness, Neoplasm
• Intervention / Treatment: Other: Immunohistochemical expression in pitNET cells of KLHL14

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 Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All consecutive cases of radiologically invasive pitNET undergoing tumor removal

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Immunohistochemical expression in pitNET cells of KLHL14; Lab essay evaluating the expression of KLHL 14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasiveness degree	The expression of KLHL14 in invasive pituitary adenomas	Invasiveness degree will be determined at the time of surgery

Collaborators and Investigators

• Sponsor: Federico II University
• Collaborators: University of Teramo
• Investigators: Principal Investigator: Barbara Barboni, PhD, University of Teramo

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 17, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Invasiveness
• Other Study ID Numbers: 17-1-j

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No