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This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting. Data from Zelboraf-treated patients with BRAF-V600 mutation-positive unresectable or metastatic melanoma will be collected for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of non-cutaneous squamous cell carcinoma | 2 years | |
| Incidence of cutaneous squamous cell carcinoma | 2 years | |
| Incidence of QT prolongation (defined as QTc >500 ms or an increase in QTc >60 ms) | 2 years | |
| Incidence of abnormal liver function | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of a second (or subsequent) primary melanoma | 2 years | |
| Incidence of gastrointestinal polyps | 2 years | |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable or metastatic melanoma treated with vemurafenib
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Feldkirch; Onkologie | Feldkirch | 6800 | Austria | |||
| Ordensklinikum Linz Elisabethinen ; Dermatologie |
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| 2 years |
| Linz |
| 4020 |
| Austria |
| Krankenhaus Hietzing Wien | Vienna | 1130 | Austria |
| ZNA Middelheim | Antwerp | 2020 | Belgium |
| CHIREC Edith Cavell | Brussels | 1180 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| FN Ostrava; Dermatology dep | Ostrava | 708 52 | Czechia |
| University Hospital Prague | Prague | 150 06 | Czechia |
| Komplexni onkologicke centrum Krajske nemocnice T. Bati, a.s. Zlin | Zlín | 760 01 | Czechia |
| Klinikum Augsburg; Hauttumorzentrum | Augsburg | 86179 | Germany |
| Charite- universitatsmedizin Berlin; Med. Klinik mit Schwerpunkt Hamatologie und Onkologie | Berlin | 12200 | Germany |
| Ruhr-Universität Bochum; Klinik für Dermatologie und Allergologie | Bochum | 44791 | Germany |
| Universitatsklinikum Bonn; Klinisches Studienzentrum Klinik fur Dermatologie | Bonn | 53105 | Germany |
| Medizinisches Zentrum | Bonn | 53111 | Germany |
| Dermatologisches Zentrum am Elbe Klinikum Buxtehude | Buxtehude | 21614 | Germany |
| DRK Krankenhaus Chemnitz-Rabenstein; Hautkrebszentrum Chemnitz | Chemnitz | 09117 | Germany |
| Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik fur Dermatologie | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf; Hautklinik | Düsseldorf | 40225 | Germany |
| Dermatologie und Allergologie HELIOS Hauttumorzentrum Erfurt | Erfurt | 99089 | Germany |
| Universitatsklinikum Essen; Klinik für Dermatologie | Essen | 45147 | Germany |
| SRH Wald-Klinikum Gera; Zentrum fur klinische Studien (ZKS) | Gera | 07548 | Germany |
| Universitaetsmedizin Goettingen; Abteilung Dermato-Onkologie | Göttingen | 37075 | Germany |
| Universitätsmedizin Greifswald; Klinik und Poliklinik für Hautkrankheiten | Greifswald | 17487 | Germany |
| Univ.- Hautklinik Heidelberg | Heidelberg | 69115 | Germany |
| Friedrich-Schiller-Universitaet Jena; Klinik fuer Dermatologie und dermatologische Allergologie | Jena | 07743 | Germany |
| Klinikum Kassel GmbH; Hauttumorzentrum HTZ | Kassel | 34125 | Germany |
| Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller | Leer | 26789 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Hauttumorzentrum Rheinpfalz | Ludwigshafen | 67063 | Germany |
| UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d | Lübeck | 23538 | Germany |
| Klinik und Poliklinik fur Dermatologie; Universitatsklinikum Mainz | Mainz | 55131 | Germany |
| Med. Fakultat Mannheim der Universitat Heidelberg; Klinik fur Dermatologie | Mannheim | 68167 | Germany |
| Johannes Wesling Klinikum Minden;Haut Tumor Centrum Minden | Minden | 32429 | Germany |
| Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie | Münster | 48149 | Germany |
| Fachklinik Hornheide; Abteilung für Dermatologie | Münster | 48157 | Germany |
| Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie | Nuremberg | 90419 | Germany |
| Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz | Quedlinburg | 06484 | Germany |
| Klinikum Vest; Behandlungszentrum Kanppschaftskrankenhaus Recklinghausen | Recklinghausen | 45657 | Germany |
| Universitätsmedizin Rostock; Klinik und Poliklinik für Dermatologie und Venerologie | Rostock | 18057 | Germany |
| Eberhard-Karls-Universitat Tubingen; Sektion Dermatologische Onkologie | Tübingen | 72076 | Germany |
| Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie | Würzburg | 97080 | Germany |
| Galway University Hospital; Clinical Trials Department | Galway | Ireland |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Policlinico S. Orsola Malpighi;Dip. Ematologia, Oncologia e Medicina di Laboratorio | Bologna | Emilia-Romagna | 40138 | Italy |
| Ausl Ravenna-Osp.Infermi; Day Hospital Oncologia Medica | Faenza | Emilia-Romagna | 48018 | Italy |
| Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia | Modena | Emilia-Romagna | 41100 | Italy |
| Ospedale "Guglielmo da Saliceto";U.O. Medicina Oncologica | Piacenza | Emilia-Romagna | 29121 | Italy |
| Azienda ASL di Rimini (Presidi di Rimini - Cattolica)) - Ospedale degli Infermi;U.O. Oncologia | Rimini | Emilia-Romagna | 47922 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milan | Lombardy | 20162 | Italy |
| Fondazione IRCCS Policlinico San Matteo, Oncologia | Pavia | Lombardy | 27100 | Italy |
| A.O.V.V. - P.O. di Sondrio; S.O.C. Oncologia Medica | Sondrio | Lombardy | 23100 | Italy |
| A.U Careggi di Firenze;Oncologia | Florence | Tuscany | 50134 | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica | Siena | Tuscany | 53100 | Italy |
| Amphia Ziekenhuis, locatie Langendijk;Oncology | Breda | 4819 EV | Netherlands |
| Academ Ziekenhuis Groningen; Medical Oncology | Groningen | 9713 GZ | Netherlands |
| Atrium MC, Parkstad Heerlen; Poli Interne | Heerlen | 6419 PC | Netherlands |
| Maastricht University Medical Center,Division of Medical Oncology; Dept. Internal Medicine | Maastricht | 6229 HX | Netherlands |
| Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii | Bydgoszcz | 85-796 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Krakow | 31-531 | Poland |
| RegioNAlny Osrodek Onkologiczny Pododdział Diagnostyki i Terapii Onkologicznej | Lodz | 93-513 | Poland |
| Regionalny Osrodek Onkologiczny; Oddzial Chorob Rozrostowych | Lodz | 93-513 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej; Opolskie Centrum Onkologii | Opole | 45-060 | Poland |
| Centrum Onkologii - Instytut, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow | Warsaw | 02-781 | Poland |
| Blekingesjukhuset; Kirurgkliniken | Karlskrona | 371 85 | Sweden |
| Karolinska University Hospital;Department of Oncology-Pathology | Stockholm | 17176 | Sweden |
| Royal Sussex County Hospital | Brighton | BN2 5BE | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Addenbrookes Hospital; Dept of Oncology | Cambridge | CB2 2QQ | United Kingdom |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| Cheltenham General Hospital; Gloucestershire Oncology Centre | Cheltenham | GL53 7AN | United Kingdom |
| Dorset County Hospital NHS Foundation Trust;Research and Development/ Oncology | Dorchester | DT1 2JY | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| St George's Hospital; Oncology | London | SW17 0QT | United Kingdom |
| Imperial College Healthcare NHS Trust;Medical Oncology | London | W6 8RF | United Kingdom |
| The Clatterbridge Cancer Ctr For Oncolgy | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| St Helens & Knowsley Trust | St Helens | WA9 3DA | United Kingdom |
| New Cross Hospital; Deansley Centre | Wolverhampton | WV10 0QP | United Kingdom |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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