Actively Recruiting
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
Led by Jules Bordet Institute · Updated on 2026-01-06
600
Participants Needed
17
Research Sites
52 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
Researchers aim to improve understanding and treatment of brain metastases from solid tumors, which currently have limited systemic treatment options. This study focuses on patients with newly diagnosed non-CNS metastatic solid tumors who are at high risk of developing central nervous system (CNS) metastases. By gathering detailed clinical and biological information, including analyses of circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF) samples, the study seeks to identify new therapeutic targets and develop innovative treatment strategies. The study is organized into three time periods: before the first CNS event (Part A), at the first CNS diagnosis (Part B), and after the first CNS event (Part C). Participants will undergo scheduled collections of plasma, serum, CSF samples, and non-CNS metastatic tumor tissue as applicable, along with brain MRI scans at specific intervals depending on their part in the study. Sample collections and imaging are scheduled annually, every few months, or as clinically indicated, aligned with the participant's cancer type and study period. Participants will have regular assessments including imaging and biological sample collections to monitor disease progression and tumor biology. Researchers will analyze the epidemiology and biology of CNS metastases over approximately eight years. Study procedures include lumbar punctures for CSF collection, brain MRIs, and collection of tumor tissue when possible. Participants' safety and life expectancy are considered, and follow-up will continue throughout the study duration to support data collection and understanding of CNS metastases.
CONDITIONS
Brief 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...
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Male or female participants
- Newly diagnosed or up to 24 months from diagnosis of non-CNS metastases (with some exceptions for certain subtypes)
- Patients presenting with a first CNS event and not previously enrolled
- Diagnosis includes one of seven cohorts: triple negative breast cancer, HER2 positive breast cancer, non-small cell lung cancer, small cell lung cancer, melanoma, other solid tumors, or leptomeningeal carcinomatosis
- Availability of primary and/or non-CNS metastatic archival tumor tissue
- Willingness to undergo lumbar puncture at CNS metastases diagnosis unless medically contraindicated
- Predicted life expectancy greater than 3 months
- Negative pregnancy test within 28 days prior to enrollment for women of childbearing potential
- Effective contraception for women of childbearing potential
- Completion of all screening procedures within 28 days prior to enrollment
- Signed informed consent form
- Affiliation to the French Social Security System (applicable in France only)
You will not qualify if you...
- Pregnant or lactating women
- Other malignancies within the last 2 years except certain skin and cervical cancers
- Uncontrolled significant medical, neuro-psychiatric, or surgical conditions that may interfere with study completion
- Vulnerable persons under legal protection or unable to give consent (applicable in France only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 28 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Varies by cancer type and participant, up to diagnosis of CNS metastases
Participants are observed before diagnosis of the first CNS event with periodic sample collections and brain MRI scans according to their cancer type.
Sample collections and brain MRI at baseline and periodic intervals (e.g., once a year, every 4 months, or every 6 months depending on cancer type)
Duration - Within 6 weeks after CNS metastases diagnosis
Participants undergo assessments and sample collections as close as possible to the diagnosis of CNS metastases, including mandatory cerebrospinal fluid sampling when clinically possible.
1 visit for sample collections (plasma, serum, CSF) and brain MRI near CNS diagnosis
Duration - Up to 96 months
Participants are monitored after CNS metastases diagnosis with periodic sample collections and brain MRI scans approximately every 3 months.
Sample collections and brain MRI every 3 months (+/- 1 month window)
Trial Site Locations
Total: 17 locations
1
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
2
Hôpital Erasme
Brussels, Belgium, 1070
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3
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
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4
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
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5
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
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6
UZ Brussel
Jette, Belgium, 1090
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7
UZ Leuven
Leuven, Belgium, 3000
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8
CHU Ambroise Paré
Mons, Belgium, 7000
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9
CHU UCL Namur - Site de Sainte-Elisabeth
Namur, Belgium, 5000
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10
Centre Oscar Lambret
Lille, France, 59020
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11
Institut Paoli-Calmettes
Marseille, France, 13273
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12
Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
Paris, France, 75020
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13
Institut Curie
Paris, France, 75248
Actively Recruiting
14
Centre Henri Becquerel
Rouen, France, 76038
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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
D
Diane Delaroche
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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