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A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours
Sponsor: Jules Bordet Institute
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.
Official title: A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2020-07-01
Completion Date
2029-01
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
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)
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
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
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)
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.
Locations (17)
Institut Jules Bordet
Anderlecht, Belgium
Hôpital Erasme
Brussels, Belgium
Cliniques Universitaires St Luc
Brussels, Belgium
Grand Hôpital de Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Brussel
Jette, Belgium
UZ Leuven
Leuven, Belgium
CHU Ambroise Paré
Mons, Belgium
CHU UCL Namur - Site de Sainte-Elisabeth
Namur, Belgium
Centre Oscar Lambret
Lille, France
Institut Paoli-Calmettes
Marseille, France
Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon
Paris, France
Institut Curie
Paris, France
Centre Henri Becquerel
Rouen, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Institut Universitaire du Cancer - Oncopole
Toulouse, France
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg