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

  • STATUS
    Recruiting
  • End date
    Jan 5, 2028
  • participants needed
    600
  • sponsor
    Jules Bordet Institute
Updated on 28 February 2021

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.

Details
Condition CNS Metastases, cns involvement
Treatment Brain MRI, Samples collection: Plasma, Samples collection: CSF, Samples collection: Non-CNS Metastatic Tumour Tissue
Clinical Study IdentifierNCT04109131
SponsorJules Bordet Institute
Last Modified on28 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have CNS Metastases?
Do you have any of these conditions: cns involvement or CNS Metastases?
Do you have any of these conditions: CNS Metastases or cns involvement?
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 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
\. Affiliated to the French Social Security System

Exclusion Criteria

Pregnant and/or lactating women
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
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
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