- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06278103
Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M) (MethylRH-M)
February 19, 2024 updated by: Guillaume GAUCHOTTE, Central Hospital, Nancy, France
Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
180
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Description
Inclusion Criteria:
- Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
immunohistochemical expression of different hormonal receptors
Time Frame: up to 24 years after surgery
|
Evaluated on FFPE sections
|
up to 24 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
methylation profile of the promoters of hormonal receptor genes
Time Frame: up to 24 years after surgery
|
Methylation profile established from frozen tissue.
|
up to 24 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2000
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
February 19, 2024
First Submitted That Met QC Criteria
February 19, 2024
First Posted (Estimated)
February 26, 2024
Study Record Updates
Last Update Posted (Estimated)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023PI113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.