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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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; - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05025969
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GCS Ramsay Santé pour l'Enseignement et la Recherche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Philippe METELLUS, MD PD
Principal Investigator Affiliation Hôpital Privé Clairval
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Additional Details

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

Arms & Interventions

Arms

: Glioma

(20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas)

: Brain metastasis

The "brain metastasis" cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available

Interventions

Other: - Glioma data collection

Glioma data collection

Other: - Brain metastasis data collection

Brain metastasis data collection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hôpital Privé Clairval, Marseille, France

Status

Address

Hôpital Privé Clairval

Marseille, , 13009