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Trial Title:
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
NCT ID:
NCT05848050
Condition:
Brain Metastases
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
monocentric, prospective, interventional, exploratory study
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
biological samples (blood test and lumbar puncture)
Description:
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.
Arm group label:
brain metastases from solid cancer
Summary:
The purpose of the study is to determine in brain metastases and according to feasibility
in liquid biopsies:
- 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.
Detailed description:
This is a single-center, prospective, interventional, exploratory study aimed at
comparing the molecular alteration profile of liquid biopsies (blood and lumbar puncture)
to that of brain metastases.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient aged 18 or over;
- 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 with a medical contraindication to surgery and anesthesia;
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Privé Clairval
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe METELLUS, MD
Email:
philippe.metellus@outlook.fr
Start date:
June 27, 2023
Completion date:
September 2024
Lead sponsor:
Agency:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class:
Other
Source:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05848050
