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

A legfontosabb adatok

Ki végzi
Jules Bordet Institute
Hol
Belgium, Franciaország és Luxemburg17 helyszín, 3 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
600 fő, tervezett
Kezdés
2020. júl. 1.
Várható befejezés
2029. jan.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Samples collection: Plasma
  • Samples collection: CSF
  • Samples collection: Non-CNS Metastatic Tumour Tissue
  • Brain MRI
  • Samples collection: Serum
A regiszteradat frissítve
2026. január 6.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with a solid tumour that has spread, and a high risk of spread to the brain or spinal cord (CNS). It collects samples and brain scans. People with a first CNS event can also join.

Életkor
18 years or older
Nem
Male or female
A betegség stádiuma
Part A: spread outside the brain and spinal cord, newly found or up to 24 months from diagnosis (some exceptions for HER2+ breast cancer and NSCLC with driver mutations). Part B: a first CNS event, not yet in the program. Cohorts: triple negative breast cancer, HER2 positive breast cancer, NSCLC, SCLC, melanoma, other solid tumours, and leptomeningeal carcinomatosis (cancer in the brain linings). ECOG performance status ≤ 2. Expected to live more than 3 months.
Biomarker vagy leletérték
Stored tumour tissue from the first tumour or from spread outside the brain must be available.

A részvétel fő kizáró okai

  • Pregnant or breastfeeding women
  • Another cancer in the last 2 years, except in situ cervix cancer or treated basal or squamous cell skin cancer
  • Serious medical, mental or surgical problem not controlled by treatment
  • In France: vulnerable persons or adults under legal protection or unable to consent

A regiszter feltételei, szó szerint

Mind a 16 feltétel megnézéseKevesebb

Ki vehet részt

  • Age ≥ 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Female or Male
  • 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
  • Availability of either primary and/or non-CNS metastatic archival tumour tissue is mandatory for inclusion
  • Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications
  • Predicted life expectancy > 3 months
  • Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment
  • Effective contraception is in place for women of childbearing potential
  • Completion of all necessary screening procedures within 28 days prior to enrolment
  • Signed Informed Consent form (ICF) obtained prior to any study related procedure; Inclusion criterion applicable to FRANCE only
  • Affiliated to the French Social Security System

Ki nem vehet részt

  • 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
  • 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
  • Pregnant and/or lactating women
  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

3 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • CNS metastases from solid tumoursEgyéb csoport

    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

    Kezelés: Samples collection: Plasma, Samples collection: CSF, Samples collection: Non-CNS Metastatic Tumour Tissue, Brain MRI és Samples collection: Serum

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 15.
A regiszteradat frissítve
2026. január 6.