Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours

Study Overview
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Brief Summary
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This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.

Detailed Description
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Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.

Official Title
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Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours

Conditions
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Glioma

Intervention / Treatment
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* Other: Glioma data collection
* Other: Brain metastasis data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female subject; Glioma or brain metastasis operated on in our institution, histologically confirmed (WHO classification 2016); Subject with a frozen tumour sample < 5 years old; Subject for whom all clinico-radiological data are available; Subject affiliated to a health insurance scheme; Subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample. Exclusion Criteria: Patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision Biological samples not available and/or in insufficient quantity for analysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glioma<br>(20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas) | Other: Glioma data collection<br>* Glioma data collection<br>|
| Brain metastasis<br>The brain metastasis cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available | Other: Brain metastasis data collection<br>* Brain metastasis data collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NTRK Fusion | Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples. | through study completion, an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NTRK Fusion identification in brain metastasis and primary tumor | Incidence of NTRK gene fusion identified in matched pairs of brain metastasis and primary tumor; | through study completion, an average of 12 months | 
| Progression-free survival in patients with NTRK gene fusion | Progression-free survival in patients with NTRK gene fusion. Progression-free survival is defined as the time from the date of initial surgery to the date of diagnosis of progression. Progression will be defined according to the RANO criteria at 6 months | Month 6 | 
| Progression-free survival in patients with NTRK gene fusion | Progression-free survival in patients with NTRK gene fusion. Progression-free survival is defined as the time from the date of initial surgery to the date of diagnosis of progression. Progression will be defined according to the RANO criteria at 12 months | Month 12 | 
| Overall survival in patients with NTRK gene fusion. | Overall survival in patients with NTRK gene fusion. Overall survival is defined as the time from the date of initial surgery to the date of death (or the date of last news) of the patient. | through study completion, an average of 12 months | 
| Specific radiological criterion (T1) | Specific radiological criteria (T1) in patients with NTRK gene fusion in gliomas and brain metastases | through study completion, an average of 12 months | 
| Specific radiological criterion (T2) | Specific radiological criteria (T2) in patients with NTRK gene fusion in gliomas and brain metastases | through study completion, an average of 12 months | 
| Specific radiological criterion (FLAIR) | Specific radiological criteria (FLAIR) in patients with NTRK gene fusion in gliomas and brain metastases | through study completion, an average of 12 months | 
| Specific radiological criterion (perfusion) | Specific radiological criteria (perfusion) in patients with NTRK gene fusion in gliomas and brain metastases | through study completion, an average of 12 months | 
| Incidence of other genomic alterations | Incidence of other genomic alterations identified by RNAseq, associated with the incidence of NTRK gene fusion | through study completion, an average of 12 months |