Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
- Conditions
- Glioma
- Interventions
- Other: Brain metastasis data collectionOther: Glioma data collection
- Registration Number
- NCT05025969
- Lead Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Brain metastasis Brain metastasis data collection The "brain metastasis" cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available Glioma Glioma data collection (20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Progression-free survival in patients with NTRK gene fusion Month 12 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
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 (perfusion) through study completion, an average of 12 months Specific radiological criteria (perfusion) 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 (T1) through study completion, an average of 12 months Specific radiological criteria (T1) in patients with NTRK gene fusion in gliomas and brain metastases
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
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
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
Trial Locations
- Locations (1)
Hôpital Privé Clairval
🇫🇷Marseille, France