NTRK Fusion: Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Glioma (20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas) |
Other: Glioma data collection
Glioma data collection
|
| Brain metastasis The "brain metastasis" cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available |
Other: Brain metastasis data collection
Brain metastasis data collection
|
Outcome Measures
Primary Outcome Measures
- 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
- 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;
- 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
- 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 (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
- 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
Eligibility Criteria
Criteria
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;
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Privé Clairval | Marseille | France | 13009 |
Sponsors and Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Investigators
- Principal Investigator: Philippe METELLUS, MD PD, Hôpital Privé Clairval
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COS-RGDS-2020-06-072