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

Meningioma Atypical Clinical Trial

— TransMenAtyp  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259332
• Other study ID #: 2020PI026
• Status: Recruiting
• Start date: February 25, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2022
• Source: Central Hospital, Nancy, France
• Contact: Guillaume GAUCHOTTE, PUPH
• Phone: +33 3 83 65 60 17
• Email: g.gauchotte[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: October 31, 2023
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Meningioma
• Meningioma Atypical

Locations

Country	Name	City	State
France	Guillaume GAUCHOTTE	Vandoeuvre Les Nancy	Lorraine

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression being defined by a growth (mm3) of the tumor objectified by imaging.	through study completion an average of 5 years.
Secondary	Tumor volume assessed by imaging pre- and post-operative	mm3; RECIST criteria	before and within 3 months after surgery
Secondary	mRNA quantities of transcripts of interest	µg.mL-1	through study completion, an average of 1 year
Secondary	Radiotherapy-induced toxicity	CTCAE scale (Common Terminology Criteria for Adverse Events) v 4.0	within 5 years after radiotherapy
Secondary	Dose of corticosteroids before and after radiotherapy	in mg	within 6 months before and after radiotherapy
Secondary	Intra-observer, inter-observer and inter-laboratory intra-class correlation coefficients of immunohistochemical markers.	Kappa coefficient	through study completion, an average of 1 year