Back to resultsEvaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases (METALIQ)
Primary Purpose
Brain Metastases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biological samples (blood test and lumbar puncture)
Sponsored by
About this trial
This is an interventional prevention trial for Brain Metastases
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.
Sites / Locations
- Hôpital Privé ClairvalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
brain metastases from solid cancer
Arm Description
Excision of the cerebral metastasis
Outcomes
Primary Outcome Measures
molecular alteration profile of liquid biopsies
Compare the molecular alteration profile of liquid biopsies (blood and CSF) to that of brain metastases.
Will be determined in brain metastases and according to feasibility in liquid biopsies (blood and CSF):
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05848050
First Posted
April 25, 2023
Last Updated
June 29, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05848050
Brief Title
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
Acronym
METALIQ
Official Title
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
monocentric, prospective, interventional, exploratory study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
brain metastases from solid cancer
Arm Type
Other
Arm Description
Excision of the cerebral metastasis
Intervention Type
Procedure
Intervention Name(s)
biological samples (blood test and lumbar puncture)
Intervention 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.
Primary Outcome Measure Information:
Title
molecular alteration profile of liquid biopsies
Description
Compare the molecular alteration profile of liquid biopsies (blood and CSF) to that of brain metastases.
Will be determined in brain metastases and according to feasibility in liquid biopsies (blood and CSF):
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe MD METELLUS
Phone
491171483
Ext
+33
Email
philippe.metellus@outlook.fr
Facility Information:
Facility Name
Hôpital Privé Clairval
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe METELLUS, MD
Email
philippe.metellus@outlook.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases
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