KLHL14 Expression as Predicting Factor of Invasiveness in pitNET

NCT ID: NCT06247709

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-12

Study Completion Date

2023-12-17

Brief Summary

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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

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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

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Invasiveness, Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Immunohistochemical expression in pitNET cells of KLHL14

Intervention Type OTHER

Lab essay evaluating the expression of KLHL 14

Interventions

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Immunohistochemical expression in pitNET cells of KLHL14

Lab essay evaluating the expression of KLHL 14

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Teramo

OTHER

Sponsor Role collaborator

Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Domenico Solari

Associate Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Barboni, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Teramo

Locations

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Federico II university

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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17-1-j

Identifier Type: -

Identifier Source: org_study_id

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