NCT05848050

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Metastases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-06-27
• Primary completion: 2025-07-25
• Completion: 2025-07-25
• First posted: 2023-05-08
• Last updated: 2025-11-24

Locations

1 site across 1 country: France