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

NCT05025969 | Completed

• 1 other identifier: COS-RGDS-2020-06-072
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• NTRK Fusion identification in brain metastasis and primary tumor

  through study completion, an average of 12 months

• Progression-free survival in patients with NTRK gene fusion

  Month 6

• Progression-free survival in patients with NTRK gene fusion

  Month 12

• Overall survival in patients with NTRK gene fusion.

  through study completion, an average of 12 months

• Specific radiological criterion (T1)

  through study completion, an average of 12 months

Study Arms (2)

Glioma

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

Other: 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

Interventions

Glioma data collection OTHER

Glioma data collection

Glioma

Brain metastasis data collection OTHER

Brain metastasis data collection

Brain metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients operated for glioma or brain metastasis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

The genomic analyses will be performed on tumour samples collected in routine practice during brain tumour removal surgery (glioma or brain metastasis) and the clinico-biological data will be collected from the medical records.

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Philippe METELLUS, MD PD

  Hôpital Privé Clairval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 30, 2021
• Study Start: October 31, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)