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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05259332

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Enrollment

Location

20.1

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Meningioma Atypical

Study Design

Study Type:

Observational

Anticipated Enrollment :

85 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Feb 25, 2022

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Oct 31, 2023

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guillaume GAUCHOTTE	Vandoeuvre Les Nancy	Lorraine	France	54511

Sponsors and Collaborators

Central Hospital, Nancy, France
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guillaume GAUCHOTTE, University professor and Hospital practitioner, Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT05259332

Other Study ID Numbers:

2020PI026

First Posted:

Feb 28, 2022

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guillaume GAUCHOTTE, University professor and Hospital practitioner, Central Hospital, Nancy, France

Transcriptome

Additional relevant MeSH terms:

Meningioma

Study Results

No Results Posted as of Feb 28, 2022