Spots Global Cancer Trial Database for Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
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Trial Identification
Brief Title: Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
Official Title: A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)
Study ID: NCT04066504
Conditions
Interventions
Study Description
Brief Summary: Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.
Detailed Description: This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Katholisches Klinikum Bochum St. Josef-Hospital, Bochum, , Germany
Elbe Kliniken Stade - Buxtehude GmbH, Buxtehude, , Germany
Klinikum Darmstadt GmbH, Darmstadt, , Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden, Dresden, , Germany
Helios Klinikum, Erfurt, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
SRH Wald-Klinikum, Gera, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaets-Hautklinik Kiel, Kiel, , Germany
Klinikum Ludwigshafen gGmbH, Ludwigshafen, , Germany
Universitaetsklinikum Schleswig-Holstein, Luebeck, , Germany
Universitätsklinik Magdeburg, Magdeburg, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Klinikum rechts der Isar, MĂźnchen, , Germany
Fachklinik Muenster-Hornheide, MĂźnster, , Germany
Helios St. Elisabeth Klinik, Oberhausen, , Germany
Harzklinikum Dorothea Christiane Erxleben GmbH, Quedlinburg, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
I.R.C.C.S Istituto Tumori "Giovanni Paolo II", Bari, , Italy
ASST Spedali Civili di Brescia, Brescia, , Italy
Azienda Toscana Centro - UniversitĂ di Firenze, Firenze, , Italy
Ospedale Policlinico San Martino, Genova, , Italy
ASL1 Avezzano-Sulmona-L'Aquila, L'Aquila, , Italy
Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST, Meldola, , Italy
Forndazione I.R.C.C.S. Istituto nazionale dei tumori, Milan, , Italy
Istituto Tumori Napoli Fondazione G. Pascale, Napoli, , Italy
UniversitĂ Degli Studi di Napoli Federico II, Napoli, , Italy
AOU Maggiore della CaritĂ - UniversitĂ del Piemonte Orientale, Novara, , Italy
IDI, Roma, , Italy
UniversitĂ Cattolica del Sacro Cuore, Roma, , Italy
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital ClĂnic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario de Gran Canaria Doctor NegrĂn, Las Palmas De Gran Canaria, , Spain
Hospital Universitario RamĂłn y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra, Pontevedra, , Spain
Hospital Universitario Nuestra SeĂąora de Candelaria, Santa Cruz De Tenerife, , Spain
Hospital General Universitari València, Valencia, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Inselspital, Bern, , Switzerland
Universitätsspital Zßrich, Zßrich, , Switzerland
Contact Details
Name: Ralf Gutzmer
Affiliation: Haut-Tumor-Zentrum Hannover
Role: PRINCIPAL_INVESTIGATOR
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