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

NCT05848050 | Completed

• 1 other identifier: 2022-A02785-38
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

brain metastases from solid cancer

OTHER

Excision of the cerebral metastasis

Procedure: biological samples (blood test and lumbar puncture)

Interventions

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.

brain metastases from solid cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 under guardianship or curatorship, or under a regime of deprivation of liberty;
• Patient not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Clairval

Marseille, 13009, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Hematologic Tests; Spinal Puncture

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biopsy; Specimen Handling; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: monocentric, prospective, interventional, exploratory study

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: June 27, 2023
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)