Glioma
Conditions
Brief summary
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
Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.
Interventions
OTHERGlioma data collection
Glioma data collection
OTHERBrain metastasis data collection
Brain metastasis data collection
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NTRK Fusion | through study completion, an average of 12 months | Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival in patients with NTRK gene fusion | Month 6 | 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 |
| Overall survival in patients with NTRK gene fusion. | through study completion, an average of 12 months | 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. |
| Specific radiological criterion (T1) | through study completion, an average of 12 months | Specific radiological criteria (T1) in patients with NTRK gene fusion in gliomas and brain metastases |
| NTRK Fusion identification in brain metastasis and primary tumor | through study completion, an average of 12 months | Incidence of NTRK gene fusion identified in matched pairs of brain metastasis and primary tumor; |
| Specific radiological criterion (FLAIR) | through study completion, an average of 12 months | Specific radiological criteria (FLAIR) in patients with NTRK gene fusion in gliomas and brain metastases |
| Specific radiological criterion (perfusion) | through study completion, an average of 12 months | Specific radiological criteria (perfusion) in patients with NTRK gene fusion in gliomas and brain metastases |
| Incidence of other genomic alterations | through study completion, an average of 12 months | Incidence of other genomic alterations identified by RNAseq, associated with the incidence of NTRK gene fusion |
| Specific radiological criterion (T2) | through study completion, an average of 12 months | Specific radiological criteria (T2) in patients with NTRK gene fusion in gliomas and brain metastases |
Countries
France
Outcome results
None listed