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Completed

NCT Number: NCT05848050

Evaluation of the Humoral and Tumoral Molecular Alteration Profile of Brain Metastases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Clairval

Marseille, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biological samples (blood test and lumbar puncture)

Procedure

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 outcomes

  1. molecular alteration profile of liquid biopsies

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Acronym: METALIQ

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 8, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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