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Completed

NCT Number: NCT05025969

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Clairval

Marseille, 13009, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glioma data collection

Other

Glioma data collection

Brain metastasis data collection

Other

Brain metastasis data collection

Primary outcomes

  1. NTRK Fusion

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

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

Secondary outcomes

  1. NTRK Fusion identification in brain metastasis and primary tumor

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

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

  2. Progression-free survival in patients with NTRK gene fusion

    Time frame: Month 6

    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

  3. Progression-free survival in patients with NTRK gene fusion

    Time frame: Month 12

    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

  4. Overall survival in patients with NTRK gene fusion.

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

    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.

  5. Specific radiological criterion (T1)

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

    Specific radiological criteria (T1) in patients with NTRK gene fusion in gliomas and brain metastases

  6. Specific radiological criterion (T2)

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

    Specific radiological criteria (T2) in patients with NTRK gene fusion in gliomas and brain metastases

  7. Specific radiological criterion (FLAIR)

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

    Specific radiological criteria (FLAIR) in patients with NTRK gene fusion in gliomas and brain metastases

  8. Specific radiological criterion (perfusion)

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

    Specific radiological criteria (perfusion) in patients with NTRK gene fusion in gliomas and brain metastases

  9. Incidence of other genomic alterations

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

    Incidence of other genomic alterations identified by RNAseq, associated with the incidence of NTRK gene fusion

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: NTRK Fusion

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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