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

Study acronym: BrainStorm
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Collaborators revised (4)v19 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (17)v18 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Jan 2027 to Jan 2028 Completion date: Jan 2028 to Jan 2029v17 Show 1 more changeShow less
    • Completion date: Jan 2028 to Jan 2029
  4. Study sites: 16 to 17v16
  5. Site contacts updated at 1 of 16 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 1 of 16 sitesv14
  2. Primary endpoints: 8 to 9 Site details revised at 5 of 16 sitesv13 Show 1 more changeShow less
    • Site details revised at 5 of 16 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Primary endpoints: 4 to 8v12 See this version in full on ClinicalTrials.gov ↗
  4. Interventions: Brain MRI (Other), Samples collection: CSF (Other), Samples collection: Non-CNS Metastatic Tumour Tissue (Other), Samples collection… to Brain MRI (Other), Samples collection: CSF (Other), Samples collection: Non-CNS Metastatic Tumour Tissue (Other), Samples collection… Eligibility criteria expanded, about 31 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 17 to 16v10
  6. Site details revised at 1 of 17 sitesv9
  7. Study sites: 16 to 17v8
  8. Study sites: 8 to 16v7
  9. Primary endpoints: 3 to 4v6 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 7 to 8v5
  11. Site details revised at 3 of 7 sitesv4
  12. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2020 to Jul 1, 2020 · Study sites: 0 to 7 · Eligibility criteria expanded, about 28 wordsv3 Show 3 more changesShow less
    • Start date changed from estimate of Jan 2020 to Jul 1, 2020
    • Study sites: 0 to 7
    • Eligibility criteria expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  13. Primary endpoints: 5 to 3v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04109131
Lead Sponsor Jules Bordet Institute
Collaborators: Fondation Cancer, Belgique, Les Amis, Bristol-Myers Squibb, Fondation Cancer, Luxembourg
Conditions CNS Metastases
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov