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RECRUITING
NCT04109131
NA

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

Sponsor: Jules Bordet Institute

View on ClinicalTrials.gov

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

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

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

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

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.

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