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

GCS Ramsay Santé pour l'Enseignement et la Recherche140 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Glioma

Interventions

Glioma data collectionOTHER

Glioma data collection

Brain metastasis data collectionOTHER

Brain metastasis data collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Privé Clairval

Marseille, France

Outcomes

Primary Outcomes

NTRK Fusion

Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples.

Time frame: through study completion, an average of 12 months

Secondary Outcomes

NTRK Fusion identification in brain metastasis and primary tumor

Incidence of NTRK gene fusion identified in matched pairs of brain metastasis and primary tumor;

Time frame: 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

Time frame: Month 6

Progression-free survival in patients with NTRK gene fusion

Time frame: 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.

Time frame: 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

Time frame: through study completion, an average of 12 months

Data from ClinicalTrials.gov

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