CNS MetastasesBrainStormNCT04109131
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
A study testing Samples collection: Plasma, Samples collection: CSF and Samples collection: Non-CNS Metastatic Tumour Tissue in people with CNS Metastases, run by Jules Bordet Institute at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Metastases
- What is being tested?
- Samples collection: Plasma, Samples collection: CSF and Samples collection: Non-CNS Metastatic Tumour Tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 1 Jul 2020to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female or Male
- 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:
Show all 21Show fewer
- 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
- Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion.
- Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
- Predicted life expectancy > 3 months.
- Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
- Effective contraception is in place for women of childbearing potential
- Completion of all necessary screening procedures within 28 days prior to enrolment.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Affiliated to the French Social Security System
Who cannot join
- Pregnant and/or lactating women.
- 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.
- 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.
- 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.
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 3 countries
Belgium9 sites, 9 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
Sylvie Bartholomeus
Andrea Gombos
- Recruiting
Hôpital Erasme
Brussels, 1070
Véronique Goblet, +32 2 541 30 39, Veronique.Goblet@erasme.ulb.ac.be
Florence Lefranc, MD
- Recruiting
Cliniques Universitaires St Luc
Brussels, 1200
Nathalie Blondeel
François Duhoux
- Recruiting
Grand Hôpital de Charleroi
Charleroi, 6000
Veronique Petre
Jean-Luc Canon
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Lore Vansteelant
Hannelore Denys
- Recruiting
UZ Brussel
Jette, 1090
Malika Tahiri
Lore Decoster
- Recruiting
UZ Leuven
Leuven, 3000
Inge Wauters, ingeborg.wauters@uzleuven.be
Paul Clement, MD
- Recruiting
CHU Ambroise Paré
Mons, 7000
Anna-Maria Barbuto
Stéphane Holbrechts
- Recruiting
CHU UCL Namur - Site de Sainte-Elisabeth
Namur, 5000
Dominique Crasson
Vincent Vanhaudenarde
France7 sites, 7 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
Solene Charpentier, s-charpentier@o-lambret.fr
Claire Cheymol, MD
- Recruiting
Institut Paoli-Calmettes
Marseille, 13273
Anthony Lombardi, LOMBARDIA@ipc.unicancer.fr
Anthony Goncalves, MD
- Recruiting
Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
Paris, 75020
Joseph Gligorov, MD, joseph.gligorov@aphp.fr
- Recruiting
Institut Curie
Paris, 75248
Imen Hafsi
Edith Borcoman, MD
- Recruiting
Centre Henri Becquerel
Rouen, 76038
Delphine Bridelance, delphine.bridelance@chb.unicancer.fr
Florian Clatot, MD
- Recruiting
Hopitaux Universitaires de Strasbourg
Strasbourg, 67200
Philippe Barthelemy, MD
Philippe Barthelemy, MD
- Recruiting
Institut Universitaire du Cancer - Oncopole
Toulouse, 31059
Marina Basmaison, Basmaison.Marina@iuct-oncopole.fr
Eleonora De Maio Desposito, MD
Luxembourg1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Luxembourg
Luxembourg, 1445
Chouaib Mediouni, chouaib.mediouni@lih.lu
Caroline Duhem, MD
About this study
Official title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
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
- Being tested
- Samples collection: Plasma, Samples collection: CSF, Samples collection: Non-CNS Metastatic Tumour Tissue, Brain MRI, Samples collection: Serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samples collection: PlasmaOther
Also called Blood for plasma preparation
At baseline
Part A:
- TNBC/ HER2+ BC: once a year
- NSCLC/SCLC: every 4 months
- Melanoma: every 6 months
Part B:
- As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
Part C:
- Every 3 months (+/- 1 month)
Samples collection: CSFOther
Also called CSF sample
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 TissueOther
Also called Non-CNS Metastatic Tumour Tissue collection
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 MRIOther
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:
- As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
Part C:
- Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)
Samples collection: SerumOther
Also called Blood for serum preparation
At baseline
Part A:
- TNBC/ HER2+ BC: once a year
- NSCLC/SCLC: every 4 months
- Melanoma: every 6 months
Part B:
- As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.
| Study group | Role | What they receive |
|---|---|---|
| CNS metastases from solid tumours | Other | 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 Receives: Other: Samples collection: Plasma; Other: Samples collection: CSF; Other: Samples collection: Non-CNS Metastatic Tumour Tissue; Other: Brain MRI; Other: Samples collection: Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Better understanding of the epidemiology of CNS metastases from solid tumours
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:
- Time to the first CNS event
- Time to the second CNS after first treatment and subsequent CNS events
Measured: through study completion, approximately 96 months
Better understanding of the epidemiology of CNS metastases from solid tumours
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including::
- Time to whole brain radiotherapy
Measured: through study completion, approximately 96 months
Better understanding of the epidemiology of CNS metastases from solid tumours
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:
- Overall survival
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
To collect data regarding the biology of CNS metastases by investigating on:
- Presence of CSF-ctDNA at diagnosis of CNS metastases
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
To collect data regarding the biology of CNS metastases by investigating on:
- Presence of plasma ctDNA at diagnosis of CNS metastases
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
- quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
- deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
- A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
- Standard analyses cytology and biochemistry analyses
Measured: through study completion, approximately 96 months
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
- Quantitative measurement of serum neuron-specific enolase
Measured: through study completion, approximately 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Jul 2020
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CNS MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Cancer, Belgique, Les Amis, Bristol-Myers Squibb, Fondation Cancer, Luxembourg
- Responsible party
- Sponsor
- Investigators
- Nuria Kotecki, MD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109131
- Sponsor's protocol ID
- IJB-BS-ODN-006
- Acronym
- BrainStorm
- Status last verified
- Jan 2026
- First submitted
- 12 Jul 2019
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arecco L, Rothe F, Venet D, Gombos A, Goncalves A, De Maio D'Esposito E, Barthelemy P, Vanhaudenarde V, Clatot F, Holbrechts S, Duhoux FP, Borcoman E, Cheymol C, Gligorov J, Denys H, Clement PM, Punie K, Duhem C, Decoster L, Canon JL, Lefranc F, Rasschaert M, Kindt N, Cular K, Gentile G, Paulus K, Pop E, Delaroche D, de Azambuja E, Awada A, Kotecki N. Cerebrospinal fluid circulating tumor DNA profiling in central nervous system metastases from solid tumors: A prospective multicentre translational analysis of the BrainStorm (OncoDistinct-006) study. J Liq Biopsy. 2026 Aug 31;14:100492. doi: 10.1016/j.jlb.2026.100492. eCollection 2026 Dec.
PubMed 42835688
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
- ClinicalTrials.gov ID
- NCT04109131
- Acronym / sponsor ID
- BrainStorm / IJB-BS-ODN-006
- Conditions
- CNS Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Collaborators
- Fondation Cancer, Belgique, Les Amis, Bristol-Myers Squibb, Fondation Cancer, Luxembourg
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CNS metastases from solid tumours | Other | Other: Samples collection: Plasma, Other: Samples collection: CSF, Other: Samples collection: Non-CNS Metastatic Tumour Tissue, Other: Brain MRI, Other: Samples collection: SerumThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Female or Male
- 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
Key exclusion criteria (4 listed)
- Pregnant and/or lactating women.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Samples collection: PlasmaAlso: Blood for plasma preparationAt 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) | Other | CNS metastases from solid tumours |
| Samples collection: CSFAlso: CSF samplePart 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 | Other | CNS metastases from solid tumours |
| Samples collection: Non-CNS Metastatic Tumour TissueAlso: Non-CNS Metastatic Tumour Tissue collectionPart 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 | Other | CNS metastases from solid tumours |
| Brain MRIPart 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) | Other | CNS metastases from solid tumours |
| Samples collection: SerumAlso: Blood for serum preparationAt 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. | Other | CNS metastases from solid tumours |
Primary outcome
Better understanding of the epidemiology of CNS metastases from solid tumours
Time frame: through study completion, approximately 96 months
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including: * Time to the first CNS event * Time to the second CNS after first treatment and subsequent CNS events
Better understanding of the epidemiology of CNS metastases from solid tumours
Time frame: through study completion, approximately 96 months
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:: - Time to whole brain radiotherapy
Better understanding of the epidemiology of CNS metastases from solid tumours
Time frame: through study completion, approximately 96 months
To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including: - Overall survival
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
To collect data regarding the biology of CNS metastases by investigating on: - Presence of CSF-ctDNA at diagnosis of CNS metastases
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
To collect data regarding the biology of CNS metastases by investigating on: - Presence of plasma ctDNA at diagnosis of CNS metastases
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
* quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS * deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
- A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
- Standard analyses cytology and biochemistry analyses
Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA.
Time frame: through study completion, approximately 96 months
- Quantitative measurement of serum neuron-specific enolase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Derived from this study: PubMed 42835688Arecco L, Rothe F, Venet D, Gombos A, Goncalves A, De Maio D'Esposito E, Barthelemy P, Vanhaudenarde V, Clatot F, Holbrechts S, Duhoux FP, Borcoman E, Cheymol C, Gligorov J, Denys H, Clement PM, Punie K, Duhem C, Decoster L, Canon JL, Lefranc F, Rasschaert M, Kindt N, Cular K, Gentile G, Paulus K, Pop E, Delaroche D, de Azambuja E, Awada A, Kotecki N. Cerebrospinal fluid circulating tumor DNA profiling in central nervous system metastases from solid tumors: A prospective multicentre translational analysis of the BrainStorm (OncoDistinct-006) study. J Liq Biopsy. 2026 Aug 31;14:100492. doi: 10.1016/j.jlb.2026.100492. eCollection 2026 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nuria Kotecki, MD study chair
Jules Bordet Institute
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples collection: Plasma, Samples collection: CSF and Samples collection: Non-CNS Metastatic Tumour Tissue in people with CNS Metastases, run by Jules Bordet Institute at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium, France, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuria Kotecki (+322541 ext. 7366, nuria.kotecki@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Better understanding of the epidemiology of CNS metastases from solid tumours (time frame: through study completion, approximately 96 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04109131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.