Informations générales (source: ClinicalTrials.gov)
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program (BrainStorm)
Interventional
N/A
Jules Bordet Institute (Voir sur ClinicalTrials)
juillet 2020
janvier 2028
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:44 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Tenon | Joseph Gligorov, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Henri Becquerel - 76038 - Rouen - France | Delphine Bridelance | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille - France | Solene Charpentier | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - 67200 - Strasbourg - France | Sherine Anajar | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - France | Anthony Lombardi | Contact (sur clinicalTrials) | |||
| Institut Universitaire du Cancer - Oncopole - 31059 - Toulouse - France | Marina Basmaison | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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.