Collaborator:
Jules Bordet Institute, Frontier Science & Technology Research Foundation, Inc.,
Studienleiter
Philippe Aftimos, MD Principal Investigator Institut Jules Bordet, Brussels, Belgium Angel Guerrero Zotano, MD Principal Investigator Instituto Valenciano de Oncologia, Valencia, Spain Matteo Benelli, PhD Principal Investigator Breast International Group
Kliniken Essen-Mitte, Klinik für Senologie/ Brustzentrum 45136 Essen (Nordrhein-Westfalen) GermanyAbgeschlossen» Google-MapsFrauenkliniken Maistrasse-Innenstadt und Großhadern 80336 München (Bayern) GermanyAktiv, nicht rekrutierend» Google-MapsInstitut Jules Bordet 1000 Brussels BelgiumRekrutierend» Google-Maps
Cliniques Universitaires St-Luc 1200 Brussels BelgiumRekrutierend» Google-MapsGrand Hopital Charleroi 6000 Charleroi BelgiumRekrutierend» Google-MapsUZ Leuven 3000 Leuven BelgiumRekrutierend» Google-MapsCHU de Liège 4000 Liège BelgiumAktiv, nicht rekrutierend» Google-MapsClinique et Maternité Sainte-Elisabeth (CMSE - Namur) 5000 Namur BelgiumRekrutierend» Google-MapsLandspitali 101 Reykjavík IcelandAktiv, nicht rekrutierend» Google-MapsOspedale degli Infermi - S.O.C.Oncologia Biella ItalyAktiv, nicht rekrutierend» Google-MapsOspedale di Bolzano - Oncologia Medica 39100 Bolzano ItalyAktiv, nicht rekrutierend» Google-MapsOspedale Ramazzini di Carpi Carpi ItalyAktiv, nicht rekrutierend» Google-MapsIRCCS AOU San Martino-IST 16132 Genova ItalyAktiv, nicht rekrutierend» Google-MapsULSS 21 Legnago 37045 Legnago ItalyAktiv, nicht rekrutierend» Google-MapsIstituto Europeo di Oncologia 20141 Milano ItalyAktiv, nicht rekrutierend» Google-MapsUOC Oncologia Medica - AOU Parma 43126 Parma ItalyAktiv, nicht rekrutierend» Google-MapsFondazione Salvatore Maugeri Pavia ItalyAktiv, nicht rekrutierend» Google-MapsIRCCS Az Ospedaliera S.Maria Nuova Reggio Emilia ItalyAktiv, nicht rekrutierend» Google-MapsCentre Hospitalier 1210 Luxembourg LuxembourgAktiv, nicht rekrutierend» Google-MapsChampalimaud Foundation 1400-038 Lisboa PortugalRekrutierend» Google-MapsComplexo Hospitalario Universitario A Coruña 15006 A Coruña SpainAktiv, nicht rekrutierend» Google-MapsHospital del Mar 08003 Barcelona SpainAktiv, nicht rekrutierend» Google-MapsDr Rosell Oncology Institute, Quirón Dexeus University Hospital 08028 Barcelona SpainAktiv, nicht rekrutierend» Google-MapsHospital Vall d'Hebron 08035 Barcelona SpainAktiv, nicht rekrutierend» Google-MapsConsorcio Hospitalario Provincial de Castellón 12002 Castellón De La Plana SpainAbgeschlossen» Google-MapsHospital San Pedro de Alcantara 10003 Cáceres SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitari Arnau de Vilanova 25198 Lleida SpainAktiv, nicht rekrutierend» Google-MapsMD Anderson Cancer Center 28033 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Clínico San Carlos 28040 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario 12 de Octubre 28041 Madrid SpainAktiv, nicht rekrutierend» Google-MapsCentro Integral Oncológico Clara Campa 28050 Madrid SpainAktiv, nicht rekrutierend» Google-MapsHospital Universitario Virgen del Rocio 41013 Sevilla SpainAbgeschlossen» Google-MapsInstituto Valenciano de Oncología 46009 Valencia SpainAktiv, nicht rekrutierend» Google-MapsHospital Clinico Universitario de Valencia 46010 Valencia SpainAktiv, nicht rekrutierend» Google-MapsHospital General Universitario de Valencia 46014 Valencia SpainAbgeschlossen» Google-MapsSahlgrenska University Hospital Gothenburg SwedenAktiv, nicht rekrutierend» Google-MapsRyhov County Hospital 55185 Jönköping SwedenAktiv, nicht rekrutierend» Google-MapsKantonsspital Baden Baden SwitzerlandAbgeschlossen» Google-MapsInselspital Bern Bern SwitzerlandAbgeschlossen» Google-MapsKantonsspital Graubuenden Chur SwitzerlandAbgeschlossen» Google-MapsLuzerner Kantonsspital, Division of Medical Oncology 6003 Lucerne SwitzerlandAbgeschlossen» Google-MapsQueen Elizabeth Hospital - University Hospitals Birmingham NHS Foundation Trust B15 2TH Birmingham United KingdomAktiv, nicht rekrutierend» Google-MapsUniversity Hospitals Bristol NHS Foundation Trust BS2 8HW Bristol United KingdomAktiv, nicht rekrutierend» Google-MapsVelindre NHS Trust CF15 7QZ Cardiff United KingdomAktiv, nicht rekrutierend» Google-MapsNHS Tayside, Ninewells Hospital DD1 9SY Dundee United KingdomAktiv, nicht rekrutierend» Google-MapsEdinburgh Cancer Centre - Western General Hospital EH4 2XU Edinburgh United KingdomAktiv, nicht rekrutierend» Google-MapsBeatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomAktiv, nicht rekrutierend» Google-MapsChristie NHS Foundation Trust Manchester United KingdomAktiv, nicht rekrutierend» Google-MapsNottingham University Hospital NHS Trust Nottingham United KingdomAktiv, nicht rekrutierend» Google-MapsSingleton Hospital - ABM University Health Board SA2 8QA Swansea United KingdomAktiv, nicht rekrutierend» Google-MapsRoyal Cornwall Hospital - Royal Cornwall Hospitals NHS Trust TR1 3LJ Truro United KingdomAktiv, nicht rekrutierend» Google-MapsYeovil District Hospital NHS Foundation Trust BA21 4AT Yeovil United KingdomAktiv, nicht rekrutierend» Google-Maps
1. Metastatic Breast Cancer (MBC) understanding (Time Frame - 1 year after end of acrrual): To improve the understanding of locally recurrent/advanced BC and MBC by using high-throughput technologies on primary, metastatic, as well as plasma ctDNA samples, to explore tumor heterogeneity, clonal evolution and transcriptional changes associated with mutational and copy number variation (CNV) patterns.
Secondary outcome:
1. Identification of "exceptional responders" and "rapid progressors"; the outlier patients (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years): To discover biomarkers of response and/or resistance to systemic therapy using genomic and transcriptomic data of "exceptional responders" and "rapid progressors" (collectively referred to as "outliers", as defined in the AURORA protocol).
2. Feasibility of implementing a global molecular screening platform for MBC (Time Frame - 1 year after end of accrual): To provide evidence that can contribute in assessing the feasibility of implementing a global molecular screening platform of MBC
3. Patient identification to match with biomarker-driven clinical trials (Time Frame - on ongoing basis during 3 years' patient recruitment): To identify patients with candidate driver alterations in their tumors that can be matched to biomarker-driven clinical trials.
4. Building new therapeutic hypotheses (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years): To build new therapeutic hypotheses based on findings generated by Targeted Gene Sequencing (TGS).
5. Patients' prognosis determination (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years): To evaluate the prognostic relevance of genomic alterations detected in plasma ctDNA samples, tumor metastatic biopsies and archived primary tissue.
6. Correlation between molecular alterations and standardly assessed efficacy endpoints (Time Frame - 1 year after end of accrual and subsequently during follow up period of 10 years): To correlate molecular alterations in patients with the efficacy endpoints (response rate, progression-free survival and overall survival).
metastatic lesion biopsy: a medical test commonly performed by a surgeon or an interventional radiologist in order to collect tissues for examination; in this case from a metastatic lesion
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer."
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