[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370882":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":47,"centralContacts":51,"locations":62,"responsibleParty":308,"collaborators":310,"id":321,"slug":322,"hasResults":323,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":323,"sex":329,"minAge":330,"maxAge":40,"enrollmentInfo":331,"targetDuration":40,"studyType":334,"phases":335,"briefSummary":337,"conditions":338,"keywords":40,"overallStatus":65,"whyStopped":40,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":349},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"CNS metastases from solid tumours","The study will be organised on three time-periods based on the time of the 1st CNS event:\n\nPart 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",[12,13,14,15,16],"Other: Samples collection: Plasma","Other: Samples collection: CSF","Other: Samples collection: Non-CNS Metastatic Tumour Tissue","Other: Brain MRI","Other: Samples collection: Serum",[18,24,30,36,41],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"Samples collection: Plasma","At baseline\n\nPart A:\n\n* TNBC\u002F HER2+ BC: once a year\n* NSCLC\u002FSCLC: every 4 months\n* Melanoma: every 6 months\n\nPart B:\n\no As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis\n\nPart C:\n\no Every 3 months (+\u002F- 1 month)",[9],[23],"Blood for plasma preparation",{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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",[9],[29],"CSF sample",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"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",[9],[35],"Non-CNS Metastatic Tumour Tissue collection",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Brain MRI","Part A:\n\n* Brain MRI at inclusion is allowed within 45 days before enrolment\n* Brain MRI pre-CNS diagnosis (Part A) : HER2 BC\u002FTNBC: once a year; NSCLC\u002FSCLC: every 4 months; Melanoma: every 6 months (+\u002F- 1 month)\n\nPart B:\n\no As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis\n\nPart C:\n\no Brain MRI post-CNS diagnosis (Part C): every 3 months (+\u002F- 1 month window)",[9],null,{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Samples collection: Serum","At baseline\n\nPart A:\n\n* TNBC\u002F HER2+ BC: once a year\n* NSCLC\u002FSCLC: every 4 months\n* Melanoma: every 6 months\n\nPart B:\n\no As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis for cohorts 1-5.",[9],[46],"Blood for serum preparation",[48],{"name":49,"affiliation":5,"role":50},"Nuria Kotecki, MD","STUDY_CHAIR",[52,58],{"name":53,"role":54,"phone":55,"phoneExt":56,"email":57},"Nuria Kotecki","CONTACT","+322541","7366","nuria.kotecki@bordet.be",{"name":59,"role":54,"phone":55,"phoneExt":60,"email":61},"Diane Delaroche","7358","diane.delaroche@bordet.be",[63,82,97,108,122,136,150,165,179,193,210,225,238,249,264,277,292],{"facility":64,"status":65,"city":66,"state":40,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Institut Jules Bordet","RECRUITING","Anderlecht","1070","Belgium","BE",{"type":71,"coordinates":72},"Point",[73,74],4.31454,50.83619,{"lat":74,"lon":73},[77,79],{"name":78,"role":54,"phone":40,"phoneExt":40,"email":40},"Sylvie Bartholomeus",{"name":80,"role":81,"phone":40,"phoneExt":40,"email":40},"Andrea Gombos","PRINCIPAL_INVESTIGATOR",{"facility":83,"status":65,"city":84,"state":40,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hôpital Erasme","Brussels",{"type":71,"coordinates":86},[87,88],4.34878,50.85045,{"lat":88,"lon":87},[91,95],{"name":92,"role":54,"phone":93,"phoneExt":40,"email":94},"Véronique Goblet","+32 2 541 30 39","Veronique.Goblet@erasme.ulb.ac.be",{"name":96,"role":81,"phone":40,"phoneExt":40,"email":40},"Florence Lefranc, MD",{"facility":98,"status":65,"city":84,"state":40,"zip":99,"country":68,"countryCode":69,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"Cliniques Universitaires St Luc","1200",{"type":71,"coordinates":101},[87,88],{"lat":88,"lon":87},[104,106],{"name":105,"role":54,"phone":40,"phoneExt":40,"email":40},"Nathalie Blondeel",{"name":107,"role":81,"phone":40,"phoneExt":40,"email":40},"François Duhoux",{"facility":109,"status":65,"city":110,"state":40,"zip":111,"country":68,"countryCode":69,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Grand Hôpital de Charleroi","Charleroi","6000",{"type":71,"coordinates":113},[114,115],4.44448,50.41136,{"lat":115,"lon":114},[118,120],{"name":119,"role":54,"phone":40,"phoneExt":40,"email":40},"Veronique Petre",{"name":121,"role":81,"phone":40,"phoneExt":40,"email":40},"Jean-Luc Canon",{"facility":123,"status":65,"city":124,"state":40,"zip":125,"country":68,"countryCode":69,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Universitair Ziekenhuis Gent","Ghent","9000",{"type":71,"coordinates":127},[128,129],3.71667,51.05,{"lat":129,"lon":128},[132,134],{"name":133,"role":54,"phone":40,"phoneExt":40,"email":40},"Lore Vansteelant",{"name":135,"role":81,"phone":40,"phoneExt":40,"email":40},"Hannelore Denys",{"facility":137,"status":65,"city":138,"state":40,"zip":139,"country":68,"countryCode":69,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"UZ Brussel","Jette","1090",{"type":71,"coordinates":141},[142,143],4.33419,50.87309,{"lat":143,"lon":142},[146,148],{"name":147,"role":54,"phone":40,"phoneExt":40,"email":40},"Malika Tahiri",{"name":149,"role":81,"phone":40,"phoneExt":40,"email":40},"Lore Decoster",{"facility":151,"status":65,"city":152,"state":40,"zip":153,"country":68,"countryCode":69,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"UZ 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Sainte-Elisabeth","Namur","5000",{"type":71,"coordinates":184},[185,186],4.86746,50.4669,{"lat":186,"lon":185},[189,191],{"name":190,"role":54,"phone":40,"phoneExt":40,"email":40},"Dominique Crasson",{"name":192,"role":81,"phone":40,"phoneExt":40,"email":40},"Vincent Vanhaudenarde",{"facility":194,"status":65,"city":195,"state":40,"zip":196,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Centre Oscar Lambret","Lille","59020","France","FR",{"type":71,"coordinates":200},[201,202],3.05512,50.63391,{"lat":202,"lon":201},[205,208],{"name":206,"role":54,"phone":40,"phoneExt":40,"email":207},"Solene Charpentier","s-charpentier@o-lambret.fr",{"name":209,"role":81,"phone":40,"phoneExt":40,"email":40},"Claire Cheymol, MD",{"facility":211,"status":65,"city":212,"state":40,"zip":213,"country":197,"countryCode":198,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Institut Paoli-Calmettes","Marseille","13273",{"type":71,"coordinates":215},[216,217],5.38107,43.29695,{"lat":217,"lon":216},[220,223],{"name":221,"role":54,"phone":40,"phoneExt":40,"email":222},"Anthony Lombardi","LOMBARDIA@ipc.unicancer.fr",{"name":224,"role":81,"phone":40,"phoneExt":40,"email":40},"Anthony Goncalves, MD",{"facility":226,"status":65,"city":227,"state":40,"zip":228,"country":197,"countryCode":198,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Institut Universitaire de Cancérologie AP-HP Sorbonne Université, Hopital Tenon","Paris","75020",{"type":71,"coordinates":230},[231,232],2.3488,48.85341,{"lat":232,"lon":231},[235],{"name":236,"role":54,"phone":40,"phoneExt":40,"email":237},"Joseph Gligorov, MD","joseph.gligorov@aphp.fr",{"facility":239,"status":65,"city":227,"state":40,"zip":240,"country":197,"countryCode":198,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Institut Curie","75248",{"type":71,"coordinates":242},[231,232],{"lat":232,"lon":231},[245,247],{"name":246,"role":54,"phone":40,"phoneExt":40,"email":40},"Imen Hafsi",{"name":248,"role":81,"phone":40,"phoneExt":40,"email":40},"Edith Borcoman, MD",{"facility":250,"status":65,"city":251,"state":40,"zip":252,"country":197,"countryCode":198,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Centre Henri Becquerel","Rouen","76038",{"type":71,"coordinates":254},[255,256],1.09932,49.44313,{"lat":256,"lon":255},[259,262],{"name":260,"role":54,"phone":40,"phoneExt":40,"email":261},"Delphine Bridelance","delphine.bridelance@chb.unicancer.fr",{"name":263,"role":81,"phone":40,"phoneExt":40,"email":40},"Florian Clatot, MD",{"facility":265,"status":65,"city":266,"state":40,"zip":267,"country":197,"countryCode":198,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Hopitaux Universitaires de Strasbourg","Strasbourg","67200",{"type":71,"coordinates":269},[270,271],7.74553,48.58392,{"lat":271,"lon":270},[274,276],{"name":275,"role":54,"phone":40,"phoneExt":40,"email":40},"Philippe Barthelemy, MD",{"name":275,"role":81,"phone":40,"phoneExt":40,"email":40},{"facility":278,"status":65,"city":279,"state":40,"zip":280,"country":197,"countryCode":198,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Institut Universitaire du Cancer - Oncopole","Toulouse","31059",{"type":71,"coordinates":282},[283,284],1.44367,43.60426,{"lat":284,"lon":283},[287,290],{"name":288,"role":54,"phone":40,"phoneExt":40,"email":289},"Marina Basmaison","Basmaison.Marina@iuct-oncopole.fr",{"name":291,"role":81,"phone":40,"phoneExt":40,"email":40},"Eleonora De Maio Desposito, MD",{"facility":293,"status":65,"city":294,"state":40,"zip":295,"country":294,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":302},"Centre Hospitalier de Luxembourg","Luxembourg","1445","LU",{"type":71,"coordinates":298},[299,300],6.13268,49.60982,{"lat":300,"lon":299},[303,306],{"name":304,"role":54,"phone":40,"phoneExt":40,"email":305},"Chouaib Mediouni","chouaib.mediouni@lih.lu",{"name":307,"role":81,"phone":40,"phoneExt":40,"email":40},"Caroline Duhem, MD",{"type":309,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[311,314,316,319],{"name":312,"class":313},"Fondation Cancer, Belgique","UNKNOWN",{"name":315,"class":313},"Les Amis",{"name":317,"class":318},"Bristol-Myers Squibb","INDUSTRY",{"name":320,"class":313},"Fondation Cancer, Luxembourg","100370882","a-brain-metastases-research-platform-to-tackle-the-challenge-of-cns-metastases-in-solid-tumours-100370882",false,"NCT04109131","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program","BrainStorm","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Female or Male\n4. 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).\n\n   Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program\n\n   Seven cohorts of subjects are defined in this prospective multicenter study:\n   * Cohort 1: Triple negative breast cancer (TNBC)\n   * Cohort 2: HER 2 positive breast cancer (HER2+ BC)\n   * Cohort 3: Non-small cell lung cancer (NSCLC)\n   * Cohort 4: Small cell lung cancer (SCLC)\n   * Cohort 5: Melanoma\n   * Cohort 6: Other solid tumours (apart from the above mentioned subtypes\n   * Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis\n5. Availability of either primary and\u002For non-CNS metastatic archival tumour tissue is mandatory for inclusion.\n6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications\n7. Predicted life expectancy \\> 3 months.\n8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment\n9. Effective contraception is in place for women of childbearing potential\n10. Completion of all necessary screening procedures within 28 days prior to enrolment.\n11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n12. Affiliated to the French Social Security System\n\nExclusion Criteria:\n\n1. Pregnant and\u002For lactating women.\n2. 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.\n3. 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.\n\n   Exclusion criterion applicable to FRANCE only\n4. 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.","ALL","18 Years",{"count":332,"type":333},600,"ESTIMATED","INTERVENTIONAL",[336],"NA","Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.\n\nBetter 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.\n\nIn 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.",[339],"CNS Metastases","2026-01-02",{"date":342,"type":343},"2026-01-06","ACTUAL",{"date":345,"type":343},"2020-07-01",{"date":347,"type":333},"2029-01",{"name":5,"class":6},17]