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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Completion Lymphadenectomy | Experimental | Completion Lymphadenectomy and monitoring afterwards |
|
| Clinical Monitoring (Palpation and node ultrasound) | Experimental | Monitoring only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Completion Lymphadenectomy | Procedure |
| ||
| Clinical Monitoring (Palpation and node ultrasound) |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastases free survival | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Distant metastases free survival | 5 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Garbe, MD | University Hopsital Tübingen | Study Director |
| Rudolf Stadler, MD | Johannes Wesling Klinikum Minden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humboldt-Universität Berlin Charité | Berlin | 10117 | Germany | |||
| Krankenhaus Neukölln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31557067 | Derived | Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer NH, Berking C, Sunderkotter C, Kaatz M, Schatton K, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Verver D, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group. Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node. J Clin Oncol. 2019 Nov 10;37(32):3000-3008. doi: 10.1200/JCO.18.02306. Epub 2019 Sep 26. | |
| 27161539 |
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| Procedure |
|
| Berlin |
| 12351 |
| Germany |
| Universtitäts-Hautklinik Bochum | Bochum | 44791 | Germany |
| Zentralkrankenhaus | Bremen | 28205 | Germany |
| Universität Köln | Cologne | 50924 | Germany |
| Carl-Thiem Klinikum | Cottbus | 03048 | Germany |
| Städtische Kliniken Darmstadt | Darmstadt | 64297 | Germany |
| Städtische Kliniken Dessau | Dessau | 06847 | Germany |
| Städtisches Klinikum Friedrichsstadt | Dresden | 01067 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Heinrich Heine Universität | Düsseldorf | 40225 | Germany |
| Klinikum Erfurt GmbH | Erfurt | 99089 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91052 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Klinkum der J. W. Goethe Universität | Frankfurt am Main | 60590 | Germany |
| Klinikum der Albert-Ludwigs-Universität | Freiburg im Breisgau | 79104 | Germany |
| Justus-Liebig-Universität | Giessen | 35385 | Germany |
| Georg-August Universität | Göttingen | 37075 | Germany |
| Allgemeines Krankenhaus St. Georg | Hamburg | 20099 | Germany |
| Klinikum de Ruprecht-Karls-Universität | Heidelberg | 69115 | Germany |
| Universitätsklinikum des Saarlandes | Homburg/Saar | 66421 | Germany |
| Klinikum der Friedrich Schiller Universität | Jena | 07740 | Germany |
| Städtische Hautklinik Karlsruhe | Karlsruhe | 76133 | Germany |
| Städtische Kliniken Kassel | Kassel | 34125 | Germany |
| Universität Leipzig | Leipzig | 04103 | Germany |
| Klinkum Lippe-Lemgo GmbH | Lemgo | 32657 | Germany |
| Universitätsklinikum Lübeck | Lübeck | 23538 | Germany |
| Otto-von-Guericke-Universität | Magdeburg | 39120 | Germany |
| Klinik der Philipps-Universität | Marburg | 35033 | Germany |
| Johannes Wesling Klinikum Minden | Minden | 32429 | Germany |
| Ludwig-Maximilians-Universität | Munich | 80337 | Germany |
| Technische Universität | Munich | 80802 | Germany |
| Städt. Krankenhaus München-Schwabing | Munich | 80804 | Germany |
| Universitätsklinkum Münster | Münster | 48149 | Germany |
| Städtische Kliniken Oldenburg | Oldenburg | 26133 | Germany |
| Klinkum der Universität | Regensburg | 93053 | Germany |
| Eberhard-Karls Universität | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Katholisches Krankenhaus | Unna | 59423 | Germany |
| Klinkum Wuppertal GmbH | Wuppertal | 42117 | Germany |
| Universitätsklinik und Poliklinik | Würzburg | 97080 | Germany |
| Derived |
| Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, Sunderkotter C, Kaatz M, Schulte KW, Lehmann P, Vogt T, Ulrich J, Herbst R, Gehring W, Simon JC, Keim U, Martus P, Garbe C; German Dermatologic Cooperative Oncology Group (DeCOG). Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):757-767. doi: 10.1016/S1470-2045(16)00141-8. Epub 2016 May 5. |
| 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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