Spots Global Cancer Trial Database for A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe
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Trial Identification
Brief Title: A Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe
Official Title: A Retrospective Observational Multicenter Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe
Study ID: NCT04937777
Conditions
Interventions
Study Description
Brief Summary: This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.
Detailed Description: The lack of regulatory approved treatment options for AL amyloidosis (AL-AMY) justifies the need to understand the current treatment practice and outcomes of this disease. There is a need for objective Real-World Evidence (RWE) that reflects how treatments are initiated, combined and sequenced, and how their relative effectiveness and safety profiles emerge outside a clinical trial setting. Therefore, the aim is to generate RWE on systemic AL-AMY patients in Europe, including patient characteristics, resource use, treatments and associated patient outcomes.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Allgemeines Krankenhaus Der Stadt Wien (General Hopsital), Universitätsklinik Für Innere Medizin I Klinische Abteilung Für Onkologie (Clinic of Internal Medicine I), Medizinische Universität Wien, Wien, , Austria
University Hospital Ostrava, Clinic of Hematooncology, Ostrava, , Czechia
Centre Hospitalier Universitaire de Limoges, Department of Clinical Hematology and Cell Therapy, Limoges, , France
Service de Néphrologie, Hémodialyse Et Transplantation Rénale, Hôpital Jean Bernard, Chu Poitiers, Poitiers, , France
Universität Heidelberg, Department of Internal Medicine V: Hematology, Oncology and Rheumatology, Heidelberg, , Germany
Alexandra Hospital, University of Athens School of Medicine, Department of Clinical Therapeutics, Athens, , Greece
Centro Per Lo Studio E La Cura Delle Amiloidosi Sistemiche Padiglione Forlanini, Pavia, , Italy
University Medical Center Groningen, Groningen, , Netherlands
University Medical Center Utrecht, Umc Utrecht, Department of Hematology, Utrecht, , Netherlands
Fundação Champalimaud, Hematology Research, Imunology - Medical School, Nova University, Lisboa, , Portugal
Centro Hospitalar E Universitário São João, Porto, , Portugal
Servicio de Hematología, Hospital Clínic de Barcelona, Barcelona, , Spain
University College London Medical School, Uk Royal Free Hospital, London, , United Kingdom
Contact Details
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