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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05259332

Acronym

TransMenAtyp

Enrollment

Registered

2022-02-28

Start date

2022-02-25

Completion date

2023-10-31

Last updated

2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningioma Atypical

Keywords

Transcriptome

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactGuillaume GAUCHOTTE, PUPH

g.gauchotte@univ-lorraine.fr+33 3 83 65 60 17

Outcome results