TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after ra
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STUDY PROTOCOL
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TRIM study protocol - a prospective randomized multicenter Trial to assess the Role of Imaging during follow-up after radical surgery of stage IIB-C and III cutaneous malignant Melanoma Ylva Naeser1,2, Hildur Helgadottir3, Yvonne Brandberg4, Johan Hansson3, Roger Olofsson Bagge5,6,7, Nils O. Elander8, Christian Ingvar9, Karolin Isaksson10,11, Petra Flygare12, Cecilia Nilsson13, Frida Jakobsson14, Olga del Val Munoz15, Antonis Valachis16, Malin Jansson17, Charlotte Sparring18, Lars Ohlsson19, Ulf Dyrke20, Dimitrios Papantoniou21, Anders Sundin22 and Gustav J. Ullenhag1,2*
Abstract Background: The incidence of cutaneous malignant melanoma (CMM) is increasing worldwide. In Sweden, over 4600 cases were diagnosed in 2018. The prognosis after radical surgery varies considerably with tumor stage. In recent years, new treatment options have become available for metastatic CMM. Early onset of treatment seems to improve outcome, which suggests that early detection of recurrent disease should be beneficial. Consequently, in several countries imaging is a part of the routine follow-up program after surgery of high risk CMM. However, imaging has drawbacks, including resources required (costs, personnel, equipment) and the radiation exposure. Furthermore, many patients experience anxiety in waiting for the imaging results and investigations of irrelevant findings is another factor that also could cause worry and lead to decreased quality of life. Hence, the impact of imaging in this setting is important to address and no randomized study has previously been conducted. The Swedish national guidelines stipulate follow-up for 3 years by clinical examinations only. (Continued on next page)
* Correspondence: [email protected] 1 Department of Immunology, Genetics and Pathology, Uppsala University, Rudbeck laboratory, 75185 Uppsala, Sweden 2 Department of Oncology, Uppsala University Hospital, entrance 101, 1tr, 75185 Uppsala, Sweden Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available
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