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A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours (BrainStorm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109131
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
La Fondation contre le cancer, Belgique
Les Amis de l'Institut Bordet
Bristol-Myers Squibb
Fondation Cancer, Luxembourg
Information provided by (Responsible Party):
Jules Bordet Institute

Brief 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. 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

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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:

  • 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 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:

  • 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: Samples collection: Serum

At 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 Name: Blood for serum preparation




Primary Outcome Measures :
  1. 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

  2. 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


  3. 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


  4. 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


  5. 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


  6. 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

  7. 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

  8. 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

  9. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nuria Kotecki +322541 ext 7366 nuria.kotecki@bordet.be
Contact: Diane Delaroche +322541 ext 7358 diane.delaroche@bordet.be

Locations
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Belgium
Institut Jules Bordet Recruiting
Anderlecht, Belgium, 1070
Contact: Sylvie Bartholomeus         
Principal Investigator: Andrea Gombos         
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         
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: Malika Tahiri         
Principal Investigator: Lore Decoster         
UZ Leuven 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: Imen Hafsi         
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: Sherine Anajar         
Principal Investigator: Philippe Barthelemy, MD         
Institut Universitaire du Cancer - Oncopole Recruiting
Toulouse, France, 31059
Contact: Marina Basmaison       Basmaison.Marina@iuct-oncopole.fr   
Principal Investigator: Eleonora De Maio Desposito, MD         
Luxembourg
Centre Hospitalier de Luxembourg Recruiting
Luxembourg, Luxembourg, 1445
Contact: Chouaib Mediouni       chouaib.mediouni@lih.lu   
Principal Investigator: Caroline Duhem, MD         
Sponsors and Collaborators
Jules Bordet Institute
La Fondation contre le cancer, Belgique
Les Amis de l'Institut Bordet
Bristol-Myers Squibb
Fondation Cancer, Luxembourg
Investigators
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Study Chair: Nuria Kotecki, MD Jules Bordet Institute
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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: June 16, 2022
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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