GliomaNTRK FusionNCT05025969
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
An observational study of Glioma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Glioma data collection and Brain metastasis data collection
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 31 Oct 2022to 8 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated for glioma or brain metastasis.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.
- Conditions
- Glioma
- Being tested
- Glioma data collection, Brain metastasis data collection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glioma data collectionOther
Glioma data collection
Brain metastasis data collectionOther
Brain metastasis data collection
| Study group | Role | What they receive |
|---|---|---|
| Glioma | (20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas) Receives: 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 Receives: Other: Brain metastasis data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
NTRK Fusion
Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples.
Measured: through study completion, an average of 12 months
Secondary outcomes (9)
NTRK Fusion identification in brain metastasis and primary tumor
Incidence of NTRK gene fusion identified in matched pairs of brain metastasis and primary tumor;
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start31 Oct 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe METELLUS, MD PD, Principal investigator, Hôpital Privé Clairval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025969
- Sponsor's protocol ID
- COS-RGDS-2020-06-072
- Acronym
- NTRK Fusion
- Status last verified
- Jun 2024
- First submitted
- 18 Aug 2021
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
- ClinicalTrials.gov ID
- NCT05025969
- Acronym / sponsor ID
- NTRK Fusion / COS-RGDS-2020-06-072
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glioma | – | Other: Glioma data collection(20 grade II gliomas, 20 grade III gliomas and 20 glioblastomas) |
| Brain metastasis | – | Other: Brain metastasis data collectionThe "brain metastasis" cohort consists of 80 patients, including 30 patients for whom the matched primary tumour is available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated for glioma or brain metastasis.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glioma data collectionGlioma data collection | Other | Glioma |
| Brain metastasis data collectionBrain metastasis data collection | Other | Brain metastasis |
Primary outcome
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.
9 secondary outcomes
NTRK Fusion identification in brain metastasis and primary tumor
Time frame: through study completion, an average of 12 months
Progression-free survival in patients with NTRK gene fusion
Time frame: Month 6
Progression-free survival in patients with NTRK gene fusion
Time frame: Month 12
Overall survival in patients with NTRK gene fusion.
Time frame: through study completion, an average of 12 months
Specific radiological criterion (T1)
Time frame: through study completion, an average of 12 months
Specific radiological criterion (T2)
Time frame: through study completion, an average of 12 months
Specific radiological criterion (FLAIR)
Time frame: through study completion, an average of 12 months
Specific radiological criterion (perfusion)
Time frame: through study completion, an average of 12 months
Incidence of other genomic alterations
Time frame: through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe METELLUS, MD PD principal investigator
Hôpital Privé Clairval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NTRK Fusion (time frame: through study completion, an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.