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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 : October 6, 2020
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

Study Description
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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 Not Applicable

Study Design
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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
Arms and Interventions
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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)


Outcome Measures
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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



Eligibility Criteria
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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 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 5 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.
Contacts and Locations
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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
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Contact: Nuria Kotecki +322541 ext 7366 nuria.kotecki@bordet.be
Contact: Chloé Velghe +322541 ext 7366 chloe.velghe@bordet.be

Locations
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Belgium
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 Not yet 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 Not yet recruiting
Jette, Belgium, 1090
Contact: Nadia Cappoen         
Principal Investigator: Lore Decoster         
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         
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 Jules Bordet Institute
More Information
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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: October 6, 2020
Last Verified: August 2020

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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
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes