NCT06247709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 12, 2024

Last Update Submit

February 7, 2024

Conditions

Invasiveness, Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Invasiveness degree

    The expression of KLHL14 in invasive pituitary adenomas

    Invasiveness degree will be determined at the time of surgery

Study Arms (1)

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

Interventions

Immunohistochemical expression in pitNET cells of KLHL14OTHER

Lab essay evaluating the expression of KLHL 14

Cases

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive cases of radiologically invasive pitNET undergoing tumor removal

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II university

Napoli, 80131, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples of pituitary adenoma cell, taken off during surgery

MeSH Terms

Conditions

Neoplasm Invasiveness

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara Barboni, PhD

    University of Teramo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neurosurgery

Study Record Dates

First Submitted

January 12, 2024

First Posted

February 8, 2024

Study Start

March 12, 2023

Primary Completion

October 31, 2023

Study Completion

December 17, 2023

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)