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

Glioma Clinical Trial

— NTRK Fusion  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05025969
• Other study ID #: COS-RGDS-2020-06-072
• Status: Not yet recruiting
• Start date: September 2021
• Est. completion date: February 2022

Study information

• Verified date: August 2021
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Philippe METELLUS, MD PD
• Phone: 04 91 17 14 83
• Email: philippe.metellus[@]outlook.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma

Intervention

Other:
• Glioma data collection
Glioma data collection
• Brain metastasis data collection
Brain metastasis data collection

Locations

Country	Name	City	State
France	Hôpital Privé Clairval	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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