NCT06278103

Brief Summary

This research aims to explore the relationship between hormonal receptor expression and the clinical and histopathological characteristics of meningiomas. The underlying hypothesis is that hormonal receptor expression, as well as the methylation profile of their gene promoters, are associated with specific aspects of meningiomas and patients' clinical outcomes. The main objective is to study the correlation between the immunohistochemical expression of hormonal receptors and clinicopathological data. The secondary objectif is to study the correlation between the methylation profile of hormonal receptor gene promoters and their immunohistochemical expression.

Trial Health

53
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
24.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

24.5 years

First QC Date

February 19, 2024

Last Update Submit

February 19, 2024

Conditions

Keywords

MeningiomaHormonal receptors

Outcome Measures

Primary Outcomes (1)

  • immunohistochemical expression of different hormonal receptors

    Evaluated on FFPE sections

    up to 24 years after surgery

Secondary Outcomes (1)

  • methylation profile of the promoters of hormonal receptor genes

    up to 24 years after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.

You may qualify if:

  • Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.

You may not qualify if:

  • Patients who did not express their consent to participate in the study.
  • Patients with grade 2 or 3 meningiomas whose samples are no longer available or in insufficient quantity to perform an immunohistochemical study.
  • Patients with grade 1 meningiomas not selected by randomization.
  • Patients withdrawing their consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

FFPE blocks. Frozen tumoral tissue.

MeSH Terms

Conditions

Meningioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
24 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 26, 2024

Study Start

January 1, 2000

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02