MeningiomaMethylRH-MNCT06278103
Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas (MethylRH-M)
An observational study of Meningioma, run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Sep 2024
- How long will I take part?
- 24 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Who may be able to join
- Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Meningioma
- Keywords
- Meningioma, Hormonal receptors
- Medical subject headings
- Meningioma
What is being measured
The primary outcome is the main question the study is designed to answer.
immunohistochemical expression of different hormonal receptors
Evaluated on FFPE sections
Measured: up to 24 years after surgery
Secondary outcomes (1)
methylation profile of the promoters of hormonal receptor genes
Methylation profile established from frozen tissue.
Measured: up to 24 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2000
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
- Target duration
- 24 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume GAUCHOTTE, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278103
- Sponsor's protocol ID
- 2023PI113
- Acronym
- MethylRH-M
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Expression of Hormonal Receptors, Clinical Data, and Methylation Profile in Meningiomas
- ClinicalTrials.gov ID
- NCT06278103
- Acronym / sponsor ID
- MethylRH-M / 2023PI113
- Conditions
- Meningioma
- Keywords
- Meningioma, Hormonal receptors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Key inclusion criteria (1 listed)
- Patients who underwent surgery for a meningioma at the University Hospital of Nancy between 2000 and 2022.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
immunohistochemical expression of different hormonal receptors
Time frame: up to 24 years after surgery
Evaluated on FFPE sections
1 secondary outcome
methylation profile of the promoters of hormonal receptor genes
Time frame: up to 24 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immunohistochemical expression of different hormonal receptors (time frame: up to 24 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.