Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
NCT ID: NCT05848050
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2023-06-27
2025-07-25
Brief Summary
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* Molecular alterations including in particular mutations, amplifications, Copy number gene variants and fusion transcripts identified by high-throughput sequencing;
* The rate of variation either in gain or in loss of expression of the different messenger Ribonucleic Acids by analysis of the transcriptome;
* Epigenetic alterations by methylation of deoxyribonucleic acid clusters by methylome chips.
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Detailed Description
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The population eligible for the study will consist of any patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision.
The study consists of comparing, between brain metastases and liquid biopsies (blood and lumbar puncture), the profiles of genomic, post-genomic and epigenetic alterations as well as the mutational load. To do this, the study only requires a lumbar puncture and a blood test.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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brain metastases from solid cancer
Excision of the cerebral metastasis
biological samples (blood test and lumbar puncture)
On the day of excision of the cerebral metastasis, additional biological samples (blood test and lumbar puncture) will be taken in the operating room.
A biological sample of the tumor tissue (brain metastases of a solid cancer with contrast uptake of at least 1 cm accessible to surgical excision) will also be taken and preserved by freezing, in accordance with current practice and after obtaining their written agreement. .
Biological samples (liquid biopsies and tumour) from patients who have explicitly expressed their consent will be kept after the end of the research as part of a biobank in order to be able to carry out any additional analyses.
Interventions
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biological samples (blood test and lumbar puncture)
On the day of excision of the cerebral metastasis, additional biological samples (blood test and lumbar puncture) will be taken in the operating room.
A biological sample of the tumor tissue (brain metastases of a solid cancer with contrast uptake of at least 1 cm accessible to surgical excision) will also be taken and preserved by freezing, in accordance with current practice and after obtaining their written agreement. .
Biological samples (liquid biopsies and tumour) from patients who have explicitly expressed their consent will be kept after the end of the research as part of a biobank in order to be able to carry out any additional analyses.
Eligibility Criteria
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Inclusion Criteria
* Patient with cerebral metastases from a solid cancer, at least one of which is accessible to surgical excision (contrast enhancement of at least 1 cm);
* Patient able to understand the information related to the study and to read the information leaflet;
* Patient having signed a written informed consent to participate in the study.
Exclusion Criteria
* Patient whose anatomical location of the cerebral metastasis contraindicates wide resection;
* Patient with a contraindication to performing a lumbar puncture;
* Pregnant, parturient or breastfeeding women;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty;
* Patient not benefiting from a social security scheme.
18 Years
ALL
No
Sponsors
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Euraxi Pharma
INDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Hôpital Privé Clairval
Marseille, , France
Countries
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Other Identifiers
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2022-A02785-38
Identifier Type: -
Identifier Source: org_study_id
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