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
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 CM...
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| Format: | Article |
| Language: | English |
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BMC
2020-12-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-020-07632-4 |
| _version_ | 1818730298033045504 |
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| author | Ylva Naeser Hildur Helgadottir Yvonne Brandberg Johan Hansson Roger Olofsson Bagge Nils O. Elander Christian Ingvar Karolin Isaksson Petra Flygare Cecilia Nilsson Frida Jakobsson Olga del Val Munoz Antonis Valachis Malin Jansson Charlotte Sparring Lars Ohlsson Ulf Dyrke Dimitrios Papantoniou Anders Sundin Gustav J. Ullenhag |
| author_facet | Ylva Naeser Hildur Helgadottir Yvonne Brandberg Johan Hansson Roger Olofsson Bagge Nils O. Elander Christian Ingvar Karolin Isaksson Petra Flygare Cecilia Nilsson Frida Jakobsson Olga del Val Munoz Antonis Valachis Malin Jansson Charlotte Sparring Lars Ohlsson Ulf Dyrke Dimitrios Papantoniou Anders Sundin Gustav J. Ullenhag |
| author_sort | Ylva Naeser |
| collection | DOAJ |
| description | 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. Methods The TRIM study is a prospective randomized multicenter trial evaluating the potential benefit of imaging and blood tests during follow-up after radical surgery for high-risk CMM, compared to clinical examinations only. Primary endpoint is overall survival (OS) at 5 years. Secondary endpoints are survival from diagnosis of relapse and health-related quality of life (HRQoL). Eligible for inclusion are patients radically operated for CMM stage IIB-C or III with sufficient renal function for iv contrast-enhanced CT and who are expected to be fit for treatment in case of recurrence. The planned number of patients is > 1300. Patients are randomized to clinical examinations for 3 years +/− whole-body imaging with CT or FDG-PET/CT and laboratory tests including S100B protein and LDH. This academic study is supported by the Swedish Melanoma Study Group. Discussion This is the first randomized prospective trial on the potential benefit of imaging as a part of the follow-up scheme after radical surgery for high-risk CMM. Results The first patient was recruited in June 2017 and as of April 2020, almost 500 patients had been included at 19 centers in Sweden. Trial registration ClinicalTrials.gov , NCT 03116412 . Registered 17 April 2017, https://clinicaltrials.gov/ct2/show/study/NCT03116412 |
| first_indexed | 2024-12-17T22:59:33Z |
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| id | doaj.art-0c95732cbbdb48428677ce4543c2d318 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-17T22:59:33Z |
| publishDate | 2020-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-0c95732cbbdb48428677ce4543c2d3182022-12-21T21:29:27ZengBMCBMC Cancer1471-24072020-12-0120111010.1186/s12885-020-07632-4TRIM 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 MelanomaYlva Naeser0Hildur Helgadottir1Yvonne Brandberg2Johan Hansson3Roger Olofsson Bagge4Nils O. Elander5Christian Ingvar6Karolin Isaksson7Petra Flygare8Cecilia Nilsson9Frida Jakobsson10Olga del Val Munoz11Antonis Valachis12Malin Jansson13Charlotte Sparring14Lars Ohlsson15Ulf Dyrke16Dimitrios Papantoniou17Anders Sundin18Gustav J. Ullenhag19Department of Immunology, Genetics and Pathology, Uppsala University, Rudbeck laboratoryDepartment of Oncology, Karolinska University Hospital SolnaDepartment of Oncology-Pathology, Karolinska InstitutetDepartment of Oncology, Karolinska University Hospital SolnaSahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of GothenburgDepartment of Oncology and Department of Biomedical and Clinical Sciences, Linköping UniversityDepartment of Surgery, Clinical Sciences, Lund UniversityDepartment of Surgery, Central Hospital KristianstadDepartment of Oncology, Sundsvall County HospitalDepartment of Oncology, Hospital of Västmanland VästeråsDepartment of Oncology, Örebro University HospitalDepartment of Oncology, Gävle County HospitalDepartment of Oncology, Faculty of Medicine and Health, Örebro UniversityDepartment of Surgical and perioperative sciences, Umeå University and Umeå University HospitalDepartment of Dermatology, Skaraborg County HospitalDepartment of Surgery, Karlstad County HospitalDepartment of Surgery, Falun County HospitalDepartment of Oncology, Ryhov County HospitalDepartment of Surgical Sciences Radiology & Molecular Imaging, Uppsala UniversityDepartment of Immunology, Genetics and Pathology, Uppsala University, Rudbeck laboratoryAbstract 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. Methods The TRIM study is a prospective randomized multicenter trial evaluating the potential benefit of imaging and blood tests during follow-up after radical surgery for high-risk CMM, compared to clinical examinations only. Primary endpoint is overall survival (OS) at 5 years. Secondary endpoints are survival from diagnosis of relapse and health-related quality of life (HRQoL). Eligible for inclusion are patients radically operated for CMM stage IIB-C or III with sufficient renal function for iv contrast-enhanced CT and who are expected to be fit for treatment in case of recurrence. The planned number of patients is > 1300. Patients are randomized to clinical examinations for 3 years +/− whole-body imaging with CT or FDG-PET/CT and laboratory tests including S100B protein and LDH. This academic study is supported by the Swedish Melanoma Study Group. Discussion This is the first randomized prospective trial on the potential benefit of imaging as a part of the follow-up scheme after radical surgery for high-risk CMM. Results The first patient was recruited in June 2017 and as of April 2020, almost 500 patients had been included at 19 centers in Sweden. Trial registration ClinicalTrials.gov , NCT 03116412 . Registered 17 April 2017, https://clinicaltrials.gov/ct2/show/study/NCT03116412https://doi.org/10.1186/s12885-020-07632-4Cutaneous malignant melanomaFollow-upFDG-PET/CTCT |
| spellingShingle | Ylva Naeser Hildur Helgadottir Yvonne Brandberg Johan Hansson Roger Olofsson Bagge Nils O. Elander Christian Ingvar Karolin Isaksson Petra Flygare Cecilia Nilsson Frida Jakobsson Olga del Val Munoz Antonis Valachis Malin Jansson Charlotte Sparring Lars Ohlsson Ulf Dyrke Dimitrios Papantoniou Anders Sundin Gustav J. Ullenhag 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 BMC Cancer Cutaneous malignant melanoma Follow-up FDG-PET/CT CT |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Cutaneous malignant melanoma Follow-up FDG-PET/CT CT |
| url | https://doi.org/10.1186/s12885-020-07632-4 |
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