Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas (TransMenAtyp)

February 18, 2022 updated by: Guillaume GAUCHOTTE, Central Hospital, Nancy, France

Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications

Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).

Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included in the collection of biological samples from the Department of Pathological Anatomy and Cytology and the Biological Resource Center (CHRU Nancy).

Description

Inclusion Criteria:

  • Primary operated patients for an atypical meningioma (WHO grade II) in the Neurosurgery department of the University Hospital of Nancy.
  • At least one postoperative follow-up visit.
  • Adult patients (>18 yo) at the time of the intervention.
  • Surgical excision.

Exclusion Criteria:

  • History of meningioma in the same location.
  • Neo-adjuvant treatment.
  • Absence of non-objection form.

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
Progression-free survival
Time Frame: through study completion an average of 5 years.
Progression being defined by a growth (mm3) of the tumor objectified by imaging.
through study completion an average of 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor volume assessed by imaging pre- and post-operative
Time Frame: before and within 3 months after surgery
mm3; RECIST criteria
before and within 3 months after surgery
mRNA quantities of transcripts of interest
Time Frame: through study completion, an average of 1 year
µg.mL-1
through study completion, an average of 1 year
Radiotherapy-induced toxicity
Time Frame: within 5 years after radiotherapy
CTCAE scale (Common Terminology Criteria for Adverse Events) v 4.0
within 5 years after radiotherapy
Dose of corticosteroids before and after radiotherapy
Time Frame: within 6 months before and after radiotherapy
in mg
within 6 months before and after radiotherapy
Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.
Time Frame: through study completion, an average of 1 year
Kappa coefficient
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

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 (Anticipated)

February 25, 2022

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI026

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.

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