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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioma
• Intervention / Treatment: Other: Glioma data collection; Other: Brain metastasis data collection

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 Type: Observational
• Enrollment (Anticipated): 1400

Contacts and Locations

• Study Contact: Name: Philippe METELLUS, MD PD; Phone Number: 33 04 91 17 14 83; Email: philippe.metellus@outlook.fr
• Study Contact Backup: Name: Emilie Bialecki; Phone Number: 33 0491171428; Email: emilie.bialecki@outlook.fr

Study Locations

• France
  • Marseille, France, 13009
    • Hôpital privé Clairval
    • Contact: Philippe METELLUS, MD PD; Phone Number: 33 04 91 17 14 83; Email: philippe.metellus@outlook.fr
    • Contact: Emilie Bialecki; Phone Number: 33 0491171428; Email: emilie.bialecki@outlook.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients operated for glioma or brain metastasis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Philippe METELLUS, MD PD, Hôpital privé Clairval

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: COS-RGDS-2020-06-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No