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Brief Title: Complete Lymph Node Dissection vs Watchful Waiting in Patients With Malignant Melanoma (Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node)
Official Title: Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
Study ID: NCT02434107
Brief Summary: Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear. This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Humboldt-Universität Berlin Charité, Berlin, , Germany
Krankenhaus Neukölln, Berlin, , Germany
Universtitäts-Hautklinik Bochum, Bochum, , Germany
Zentralkrankenhaus, Bremen, , Germany
Carl-Thiem Klinikum, Cottbus, , Germany
Städtische Kliniken Darmstadt, Darmstadt, , Germany
Städtische Kliniken Dessau, Dessau, , Germany
Städtisches Klinikum Friedrichsstadt, Dresden, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Heinrich Heine Universität, Düsseldorf, , Germany
Klinikum Erfurt GmbH, Erfurt, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinkum der J. W. Goethe Universität, Frankfurt/Main, , Germany
Klinikum der Albert-Ludwigs-Universität, Freiburg, , Germany
Justus-Liebig-Universität, Giessen, , Germany
Georg-August Universität, Göttingen, , Germany
Allgemeines Krankenhaus St. Georg, Hamburg, , Germany
Klinikum de Ruprecht-Karls-Universität, Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Klinikum der Friedrich Schiller Universität, Jena, , Germany
Städtische Hautklinik Karlsruhe, Karlsruhe, , Germany
Städtische Kliniken Kassel, Kassel, , Germany
Universität Köln, Köln, , Germany
Universität Leipzig, Leipzig, , Germany
Klinkum Lippe-Lemgo GmbH, Lemgo, , Germany
Universitätsklinikum Lübeck, Lübeck, , Germany
Otto-von-Guericke-Universität, Magdeburg, , Germany
Klinik der Philipps-Universität, Marburg, , Germany
Johannes Wesling Klinikum Minden, Minden, , Germany
Ludwig-Maximilians-Universität, Munich, , Germany
Technische Universität, Munich, , Germany
Städt. Krankenhaus München-Schwabing, Munich, , Germany
Universitätsklinkum Münster, Münster, , Germany
Städtische Kliniken Oldenburg, Oldenburg, , Germany
Klinkum der Universität, Regensburg, , Germany
Eberhard-Karls Universität, Tübingen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Katholisches Krankenhaus, Unna, , Germany
Klinkum Wuppertal GmbH, Wuppertal, , Germany
Universitätsklinik und Poliklinik, Würzburg, , Germany
Name: Claus Garbe, MD
Affiliation: University Hopsital Tübingen
Role: STUDY_DIRECTOR
Name: Rudolf Stadler, MD
Affiliation: Johannes Wesling Klinikum Minden
Role: STUDY_CHAIR