A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours (BrainStorm)
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ClinicalTrials.gov Identifier: NCT04109131 |
Recruitment Status :
Recruiting
First Posted : September 30, 2019
Last Update Posted : May 17, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
CNS Metastases | Other: Samples collection: Plasma Other: Samples collection: CSF Other: Samples collection: Non-CNS Metastatic Tumour Tissue Other: Brain MRI Other: Samples collection: Serum | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 600 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | January 2027 |
Estimated Study Completion Date : | January 2028 |
Arm | Intervention/treatment |
---|---|
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 |
Other: Samples collection: Plasma
At baseline Part A:
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 Name: Blood for plasma preparation 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
Other Name: CSF sample 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
Other Name: Non-CNS Metastatic Tumour Tissue collection Other: Brain MRI Part A:
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: Samples collection: Serum At baseline Part A:
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 Name: Blood for serum preparation |
- 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
- 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
- Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. [ Time Frame: through study completion, approximately 96 months ]
To collect data regarding the biology of CNS metastases by investigating on :
- Time to the first CNS event
- Time to the second CNS event
- Time to whole brain radiotherapy (WBR)
- Time from the date of diagnosis of the first CNS event and the time of death by any cause
- Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. [ Time Frame: through study completion, approximately 96 months ]Levels of neuron specific enolase in blood
- Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. [ Time Frame: through study completion, approximately 96 months ]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. 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. Subsequently targeted gene sequencing will be performed on DNA samples from CSF and plasma in case of at least 5% tumour mutant allele frequency (MAF) and CNS metastases in case of surgery.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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:
- 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.
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Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Inclusion criterion applicable to FRANCE only
- Affiliated to the French Social Security System
Exclusion Criteria:
- 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.
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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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109131
Contact: Nuria Kotecki | +322541 ext 7366 | nuria.kotecki@bordet.be | |
Contact: Diane Delaroche | +322541 ext 7358 | diane.delaroche@bordet.be |
Belgium | |
Hôpital Erasme | Recruiting |
Brussels, Belgium, 1070 | |
Contact: Véronique Goblet +32 2 541 30 39 Veronique.Goblet@erasme.ulb.ac.be | |
Principal Investigator: Florence Lefranc, MD | |
Institut Jules Bordet | Recruiting |
Bruxelles, Belgium, 1000 | |
Contact: Sylvie Bartholomeus | |
Principal Investigator: Andrea Gombos | |
Cliniques Universitaires St Luc | Recruiting |
Bruxelles, Belgium, 1200 | |
Contact: Nathalie Blondeel | |
Principal Investigator: François Duhoux | |
Grand Hôpital de Charleroi | Recruiting |
Charleroi, Belgium, 6000 | |
Contact: Veronique Petre | |
Principal Investigator: Jean-Luc Canon | |
Universitair Ziekenhuis Gent | Recruiting |
Gent, Belgium, 9000 | |
Contact: Lore Vansteelant | |
Principal Investigator: Hannelore Denys | |
UZ Brussel | Recruiting |
Jette, Belgium, 1090 | |
Contact: Nadia Cappoen | |
Principal Investigator: Lore Decoster | |
UZ Leuven | Not yet recruiting |
Leuven, Belgium, 3000 | |
Contact: Inge Wauters ingeborg.wauters@uzleuven.be | |
Principal Investigator: Kevin Punie, MD | |
CHU Ambroise Paré | Recruiting |
Mons, Belgium, 7000 | |
Contact: Anna-Maria Barbuto | |
Principal Investigator: Stéphane Holbrechts | |
CHU UCL Namur - Site de Sainte-Elisabeth | Recruiting |
Namur, Belgium, 5000 | |
Contact: Dominique Crasson | |
Principal Investigator: Vincent Vanhaudenarde | |
France | |
Centre Oscar Lambret | Recruiting |
Lille, France, 59020 | |
Contact: Solene Charpentier s-charpentier@o-lambret.fr | |
Principal Investigator: Claire Cheymol, MD | |
Institut Paoli-Calmettes | Recruiting |
Marseille, France, 13273 | |
Contact: Anthony Lombardi LOMBARDIA@ipc.unicancer.fr | |
Principal Investigator: Anthony Goncalves, MD | |
Institut Curie | Recruiting |
Paris, France, 75248 | |
Contact: Anne Blondel anne.blondel@curie.fr | |
Principal Investigator: Edith Borcoman, MD | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Delphine Bridelance delphine.bridelance@chb.unicancer.fr | |
Principal Investigator: Florian Clatot, MD | |
CHU Strasbourg | Recruiting |
Strasbourg, France, 67200 | |
Contact: Anais Robert anais.robert@chru-strasbourg.fr | |
Principal Investigator: Philippe Barthelemy, MD | |
Institut Universitaire du Cancer - Oncopole | Recruiting |
Toulouse, France, 31059 | |
Contact: Marina Basmaison Basmaison.Marina@iuct-oncopole.fr | |
Principal Investigator: Jean-Pierre Delord, MD | |
Luxembourg | |
Centre Hospitalier de Luxembourg | Recruiting |
Luxembourg, Luxembourg, 1445 | |
Contact: Chouaib Mediouni chouaib.mediouni@lih.lu | |
Principal Investigator: Caroline Duhem, MD |
Study Chair: | Nuria Kotecki, MD | Jules Bordet Institute |
Responsible Party: | Jules Bordet Institute |
ClinicalTrials.gov Identifier: | NCT04109131 |
Other Study ID Numbers: |
IJB-BS-ODN-006 |
First Posted: | September 30, 2019 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | September 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasm Metastasis Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |