Actively Recruiting
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
Led by Jules Bordet Institute · Updated on 2026-01-06
600
Participants Needed
17
Research Sites
443 weeks
Total Duration
On this page
Sponsors
J
Jules Bordet Institute
Lead Sponsor
F
Fondation Cancer, Belgique
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Age ≥ 18 years old
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Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
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Female or Male
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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
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Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
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Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
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Predicted life expectancy > 3 months.
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Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
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Effective contraception is in place for women of childbearing potential
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Completion of all necessary screening procedures within 28 days prior to enrolment.
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Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Inclusion criterion applicable to FRANCE only
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Affiliated to the French Social Security System
You will not qualify if you...
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Pregnant and/or lactating women.
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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.
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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
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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.
AI-Screening
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Trial Site Locations
Total: 17 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Hôpital Erasme
Brussels, Belgium, 1070
Actively Recruiting
3
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Actively Recruiting
4
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
Actively Recruiting
5
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
6
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
7
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
8
CHU Ambroise Paré
Mons, Belgium, 7000
Actively Recruiting
9
CHU UCL Namur - Site de Sainte-Elisabeth
Namur, Belgium, 5000
Actively Recruiting
10
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
11
Institut Paoli-Calmettes
Marseille, France, 13273
Actively Recruiting
12
Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
Paris, France, 75020
Actively Recruiting
13
Institut Curie
Paris, France, 75248
Actively Recruiting
14
Centre Henri Becquerel
Rouen, France, 76038
Actively Recruiting
15
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67200
Actively Recruiting
16
Institut Universitaire du Cancer - Oncopole
Toulouse, France, 31059
Actively Recruiting
17
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1445
Actively Recruiting
Research Team
N
Nuria Kotecki
CONTACT
D
Diane Delaroche
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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