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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age ≥ 18 years old 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 3. Female or Male 4. 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 12. Affiliated to the French Social Security System

Exclusion Criteria:

1. Pregnant and/or lactating women. 2. 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. 3. 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 4. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04109131
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jules Bordet Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nuria Kotecki
Principal Investigator Affiliation Jules Bordet Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOtherIndustryOther
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

CNS Metastases
Arms & Interventions

Arms

Other: CNS metastases from solid tumours

The study will be organised on three time-periods based on the time of the 1st CNS event: Part A - Pre-diagnosis period: before diagnosis of the 1st CNS event Part B - At 1st CNS diagnosis period Part C - Post diagnosis period: after the 1st CNS event

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut Jules Bordet, Bruxelles, Belgium

Status

Recruiting

Address

Institut Jules Bordet

Bruxelles, , 1000

Site Contact

Sylvie Bartholomeus

nuria.kotecki@bordet.be

+322541

Cliniques Universitaires St Luc, Bruxelles, Belgium

Status

Recruiting

Address

Cliniques Universitaires St Luc

Bruxelles, , 1200

Site Contact

Nathalie Blondeel

nuria.kotecki@bordet.be

+322541

Grand Hôpital de Charleroi, Charleroi, Belgium

Status

Not yet recruiting

Address

Grand Hôpital de Charleroi

Charleroi, , 600

Site Contact

Veronique Petre

nuria.kotecki@bordet.be

+322541

Universitair Ziekenhuis Gent, Gent, Belgium

Status

Not yet recruiting

Address

Universitair Ziekenhuis Gent

Gent, , 9000

Site Contact

Lore Vansteelant

nuria.kotecki@bordet.be

+322541

UZ Brussel, Jette, Belgium

Status

Not yet recruiting

Address

UZ Brussel

Jette, , 1090

Site Contact

Nadia Cappoen

nuria.kotecki@bordet.be

+322541

CHU Ambroise Paré, Mons, Belgium

Status

Not yet recruiting

Address

CHU Ambroise Paré

Mons, , 7000

Site Contact

Anna-Maria Barbuto

nuria.kotecki@bordet.be

+322541

CHU UCL Namur - Site de Sainte-Elisabeth, Namur, Belgium

Status

Recruiting

Address

CHU UCL Namur - Site de Sainte-Elisabeth

Namur, , 5000

Site Contact

Dominique Crasson

nuria.kotecki@bordet.be

+322541

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