A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours

NCT ID: NCT04109131

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2029-01-31

Brief Summary

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.

In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Conditions

CNS Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CNS metastases from solid tumours

The study will be organised on three time-periods based on the time of the 1st CNS event:

Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event

Group Type: OTHER

Samples collection: Plasma

Intervention Type: OTHER

At baseline

Part A:

• TNBC/ HER2+ BC: once a year
• NSCLC/SCLC: every 4 months
• Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Every 3 months (+/- 1 month)

Samples collection: CSF

Intervention Type: OTHER

Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice

Samples collection: Non-CNS Metastatic Tumour Tissue

Intervention Type: OTHER

Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Brain MRI

Intervention Type: OTHER

Part A:

• Brain MRI at inclusion is allowed within 45 days before enrolment
• Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Samples collection: Serum

Intervention Type: OTHER

At baseline

Part A:

• TNBC/ HER2+ BC: once a year
• NSCLC/SCLC: every 4 months
• Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.

Interventions

Samples collection: Plasma

At baseline

Part A:

• TNBC/ HER2+ BC: once a year
• NSCLC/SCLC: every 4 months
• Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Every 3 months (+/- 1 month)

Intervention Type: OTHER

Samples collection: CSF

Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice

Intervention Type: OTHER

Samples collection: Non-CNS Metastatic Tumour Tissue

Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Intervention Type: OTHER

Brain MRI

Part A:

• Brain MRI at inclusion is allowed within 45 days before enrolment
• Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis

Part C:

o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)

Intervention Type: OTHER

Samples collection: Serum

At baseline

Part A:

• TNBC/ HER2+ BC: once a year
• NSCLC/SCLC: every 4 months
• Melanoma: every 6 months

Part B:

o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.

Intervention Type: OTHER

Other Intervention Names

Blood for plasma preparation; CSF sample; Non-CNS Metastatic Tumour Tissue collection; Blood for serum preparation

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years old

2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

3. Female or Male

4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).

Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program

Seven cohorts of subjects are defined in this prospective multicenter study:

• Cohort 1: Triple negative breast cancer (TNBC)
• Cohort 2: HER 2 positive breast cancer (HER2+ BC)
• Cohort 3: Non-small cell lung cancer (NSCLC)
• Cohort 4: Small cell lung cancer (SCLC)
• Cohort 5: Melanoma
• Cohort 6: Other solid tumours (apart from the above mentioned subtypes
• Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis

5. Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.

6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications

7. Predicted life expectancy > 3 months.

8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment

9. Effective contraception is in place for women of childbearing potential

10. Completion of all necessary screening procedures within 28 days prior to enrolment.

11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.

Inclusion criterion applicable to FRANCE only

12. Affiliated to the French Social Security System

Exclusion Criteria

1. Pregnant and/or lactating women.

2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.

3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.

Exclusion criterion applicable to FRANCE only

4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Cancer, Belgique

UNKNOWN

Sponsor Role: collaborator

Les Amis

UNKNOWN

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Fondation Cancer, Luxembourg

UNKNOWN

Sponsor Role: collaborator

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nuria Kotecki, MD

Role: STUDY_CHAIR

Jules Bordet Institute

Locations

Institut Jules Bordet

Anderlecht, , Belgium

Site Status: RECRUITING

Hôpital Erasme

Brussels, , Belgium

Site Status: RECRUITING

Cliniques Universitaires St Luc

Brussels, , Belgium

Site Status: RECRUITING

Grand Hôpital de Charleroi

Charleroi, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status: RECRUITING

UZ Brussel

Jette, , Belgium

Site Status: RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

CHU Ambroise Paré

Mons, , Belgium

Site Status: RECRUITING

CHU UCL Namur - Site de Sainte-Elisabeth

Namur, , Belgium

Site Status: RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status: RECRUITING

Institut Paoli-Calmettes

Marseille, , France

Site Status: RECRUITING

Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon

Paris, , France

Site Status: RECRUITING

Institut Curie

Paris, , France

Site Status: RECRUITING

Centre Henri Becquerel

Rouen, , France

Site Status: RECRUITING

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Institut Universitaire du Cancer - Oncopole

Toulouse, , France

Site Status: RECRUITING

Centre Hospitalier de Luxembourg

Luxembourg, , Luxembourg

Site Status: RECRUITING

Countries

Belgium; France; Luxembourg

Central Contacts

Nuria Kotecki

Role: CONTACT

nuria.kotecki@bordet.be

+322541 ext. 7366

Diane Delaroche

Role: CONTACT

diane.delaroche@bordet.be

+322541 ext. 7358

Facility Contacts

Sylvie Bartholomeus

Role: primary

Véronique Goblet

Role: primary

Veronique.Goblet@erasme.ulb.ac.be

+32 2 541 30 39

Nathalie Blondeel

Role: primary

Veronique Petre

Role: primary

Lore Vansteelant

Role: primary

Malika Tahiri

Role: primary

Inge Wauters

Role: primary

ingeborg.wauters@uzleuven.be

Anna-Maria Barbuto

Role: primary

Dominique Crasson

Role: primary

Solene Charpentier

Role: primary

s-charpentier@o-lambret.fr

Anthony Lombardi

Role: primary

LOMBARDIA@ipc.unicancer.fr

Joseph Gligorov, MD

Role: primary

joseph.gligorov@aphp.fr

Imen Hafsi

Role: primary

Delphine Bridelance

Role: primary

delphine.bridelance@chb.unicancer.fr

Philippe Barthelemy, MD

Role: primary

Marina Basmaison

Role: primary

Basmaison.Marina@iuct-oncopole.fr

Chouaib Mediouni

Role: primary

chouaib.mediouni@lih.lu

Other Identifiers

IJB-BS-ODN-006

Identifier Type: -

Identifier Source: org_study_id