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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04109131
Other study ID # IJB-BS-ODN-006
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date January 2028

Study information

Verified date January 2023
Source Jules Bordet Institute
Contact Nuria Kotecki
Phone +322541
Email nuria.kotecki@bordet.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


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Intervention

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Sponsors (5)

Lead Sponsor Collaborator
Jules Bordet Institute Bristol-Myers Squibb, Fondation Cancer, Luxembourg, La Fondation contre le cancer, Belgique, Les Amis de l'Institut Bordet

Countries where clinical trial is conducted

Belgium,  France,  Luxembourg, 

Outcome

Type Measure Description Time frame Safety issue
Other Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. To collect data regarding the biology of CNS metastases by investigating on :
Time to the first CNS event
Time to the second CNS event
Time to whole brain radiotherapy (WBR)
Time from the date of diagnosis of the first CNS event and the time of death by any cause
through study completion, approximately 96 months
Other Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. Levels of neuron specific enolase in blood through study completion, approximately 96 months
Other Better understand the predictive value of NSE for the development of CNS metastases on subjects with newly diagnosed non-CNS metastatic solid tumours with high risk of developing CNS metastases. Deep targeted next-generation sequencing (NGS) on DNA samples from primary or non CNS metastases as well as germline DNA samples and CNS metastases if surgery. A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS. Subsequently targeted gene sequencing will be performed on DNA samples from CSF and plasma in case of at least 5% tumour mutant allele frequency (MAF) and CNS metastases in case of surgery. through study completion, approximately 96 months
Primary Better understanding of the epidemiology of CNS metastases from solid tumours 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
through study completion, approximately 96 months
Primary Better understanding of the epidemiology of CNS metastases from solid tumours 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
through study completion, approximately 96 months
Primary Better understanding of the epidemiology of CNS metastases from solid tumours To collect data regarding the epidemiology of CNS metastases from solid tumours and identify risk factors for CNS metastases development, including:
- Overall survival
through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. To collect data regarding the biology of CNS metastases by investigating on:
- Presence of CSF-ctDNA at diagnosis of CNS metastases
through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. To collect data regarding the biology of CNS metastases by investigating on:
- Presence of plasma ctDNA at diagnosis of CNS metastases
through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS
deep targeted next-generation sequencing (NGS) on DNA samples from primary or non-CNS metastases as well as germline DNA samples and CNS metastases if surgery
through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. - A set of 1-3 point mutations (single nucleotide variants) will be selected for each subject based on the above analyses for the identification and quantification of plasma ctDNA and CSF-ctDNA using deep targeted NGS through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. - Standard analyses cytology and biochemistry analyses through study completion, approximately 96 months
Primary Better understand the biology of CNS metastases (brain and leptomeningeal carcinomatosis) using CSF-ctDNA as a surrogate endpoint for CNS tumour tissue DNA. - Quantitative measurement of serum neuron-specific enolase through study completion, approximately 96 months
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