New research platform aims to unlock secrets of brain metastases
NCT ID NCT04109131
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with solid tumors that have spread to the brain. Researchers want to collect medical information and samples (like blood and spinal fluid) to better understand why and how brain metastases happen. The goal is to find new ways to treat or prevent them in the future. About 600 participants will join this observational research program.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
17 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Ambroise Paré
RECRUITINGMons, 7000, Belgium
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CHU UCL Namur - Site de Sainte-Elisabeth
RECRUITINGNamur, 5000, Belgium
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Centre Henri Becquerel
RECRUITINGRouen, 76038, France
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Centre Hospitalier de Luxembourg
RECRUITINGLuxembourg, 1445, Luxembourg
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Centre Oscar Lambret
RECRUITINGLille, 59020, France
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Cliniques Universitaires St Luc
RECRUITINGBrussels, 1200, Belgium
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Grand Hôpital de Charleroi
RECRUITINGCharleroi, 6000, Belgium
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Hopitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67200, France
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Hôpital Erasme
RECRUITINGBrussels, 1070, Belgium
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Institut Curie
RECRUITINGParis, 75248, France
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Institut Jules Bordet
RECRUITINGAnderlecht, 1070, Belgium
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Institut Paoli-Calmettes
RECRUITINGMarseille, 13273, France
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Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
RECRUITINGParis, 75020, France
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Institut Universitaire du Cancer - Oncopole
RECRUITINGToulouse, 31059, France
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UZ Brussel
RECRUITINGJette, 1090, Belgium
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UZ Leuven
RECRUITINGLeuven, 3000, Belgium
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Universitair Ziekenhuis Gent
RECRUITINGGhent, 9000, Belgium
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