Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases (METALIQ)

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.

Study Overview

• Status: Completed
• Conditions: Brain Metastases
• Intervention / Treatment: Procedure: biological samples (blood test and lumbar puncture)

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Hopital Prive Clairval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: brain metastases from solid cancer; Excision of the cerebral metastasis

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): July 25, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Biopsy; Diagnostic Techniques, Neurological; Spinal Puncture; Hematologic Tests
• Other Study ID Numbers: 2022-A02785-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No