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

• Conditions: Meningioma Atypical

• Registration Number: NCT05259332
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study Start: 2022-02-25
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2022-04-01
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.	through study completion, an average of 1 year	Kappa coefficient
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

Trial Locations

Locations (1)

Guillaume GAUCHOTTE; 🇫🇷 Vandoeuvre Les Nancy, Lorraine, France