A platform to study brain metastases in solid tumors
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
This study is trying to find better treatments for patients with solid tumors that are likely to spread to the brain by collecting and analyzing their tumor samples and health data.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 17 sites (Anderlecht and 16 other locations) |
| Trial ID | NCT04109131 on ClinicalTrials.gov |
What this trial studies
This initiative aims to create a multidisciplinary clinical research platform called BrainStorm, focusing on patients with newly diagnosed non-CNS metastatic solid tumors that are at high risk of developing CNS metastases. The program will build a comprehensive clinico-pathological database, including analyses of circulating tumor DNA from cerebrospinal fluid samples. By understanding the biology and epidemiology of brain metastases, the study seeks to identify new therapeutic targets and improve treatment strategies for affected patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed non-CNS metastatic solid tumors or those presenting with a first CNS event.
Not a fit: Patients with primary CNS tumors or those who do not have solid tumors with a high risk of CNS metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options and outcomes for patients with CNS metastases from solid tumors.
How similar studies have performed: While there have been studies focusing on CNS metastases, this specific multidisciplinary approach is relatively novel and aims to address gaps in current treatment strategies.
Eligibility criteria
Show full 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. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).
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 2 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.
Where this trial is running
Anderlecht and 16 other locations
- Institut Jules Bordet — Anderlecht, Belgium (Recruiting)
- Hôpital Erasme — Brussels, Belgium (Recruiting)
- Cliniques Universitaires St Luc — Brussels, Belgium (Recruiting)
- Grand Hôpital de Charleroi — Charleroi, Belgium (Recruiting)
- Universitair Ziekenhuis Gent — Ghent, Belgium (Recruiting)
- UZ Brussel — Jette, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU Ambroise Paré — Mons, Belgium (Recruiting)
- CHU UCL Namur - Site de Sainte-Elisabeth — Namur, Belgium (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
- Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon — Paris, France (Recruiting)
- Institut Curie — Paris, France (Recruiting)
- Centre Henri Becquerel — Rouen, France (Recruiting)
- Hopitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
- Institut Universitaire du Cancer - Oncopole — Toulouse, France (Recruiting)
- Centre Hospitalier de Luxembourg — Luxembourg, Luxembourg (Recruiting)
Study contacts
- Study coordinator: Nuria Kotecki
- Email: nuria.kotecki@bordet.be
- Phone: +322541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.