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

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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

Naeser, Ylva (författare): Uppsala University,Uppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital,Uppsala Univ, Sweden; Uppsala Univ Hosp, Sweden

Helgadottir, H. (författare): Karolinska Institutet

Brandberg, Y. (författare): Karolinska Institutet,Karolinska Institute,Karolinska Inst, Sweden

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Jansson, Malin (författare): Umeå University,Umeå universitet,Kirurgi,Umeå University Hospital, Umeå, Sweden,Umeå Univ, Dept Surg & Perioperat Sci, S-90185 Umeå, Sweden.;Umeå Univ Hosp, S-90185 Umeå, Sweden.,Norrland University Hospital

Olofsson Bagge, Roger, 1978 (författare): University of Gothenburg,Gothenburg University,Göteborgs universitet,Sahlgrenska Cancer Center,Wallenberg Centre for Molecular and Translational Medicine,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Sahlgrenska Cancer Center, Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden; Wallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden,Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Surg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Surg, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.

Elander, Nils (författare): Linköpings universitet,Linköping University,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US

Ingvar, Christian (författare): Lund University,Lunds universitet,Lunds Melanomstudiegrupp,Forskargrupper vid Lunds universitet,Lund Melanoma Study Group,Lund University Research Groups,Lund Univ, Sweden

Isaksson, Karolin (författare): Lund University,Lunds universitet,Lunds Melanomstudiegrupp,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Lund Melanoma Study Group,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Central Hospital Kristianstad,Cent Hosp Kristianstad, Sweden; Lund Univ, Sweden

Flygare, P. (författare): Department of Oncology, Sundsvall County Hospital, Sundsvall, Sweden,Sundsvall Cty Hosp, Dept Oncol, Lasarettsgatan 21, S-85643 Sundsvall, Sweden.

Nilsson, C. (författare): Department of Oncology, Hospital of Västmanland Västerås, Västerås, Sweden,Hosp Vastmanland Västerås, Dept Oncol, S-72189 Västerås, Sweden.

Jakobsson, F. (författare): Department of Oncology, Örebro University Hospital, Örebro, Sweden,Örebro Univ Hosp, Dept Oncol, S-70185 Örebro, Sweden.

del Val Munoz, O. (författare): Department of Oncology, Gävle County Hospital, Gävle, Sweden,Gävle Cty Hosp, Dept Oncol, S-80187 Gävle, Sweden.

Valachis, Antonis, 1984- (författare): Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Department of Oncology,Örebro Univ, Fac Med & Hlth, Dept Oncol, S-70182 Örebro, Sweden.

Jansson, M. (författare)

Sparring, C. (författare): Department of Dermatology, Skaraborg County Hospital, Skövde, Sweden,Skaraborg Cty Hosp, Dept Dermatol, S-54185 Skövde, Sweden.

Ohlsson, L. (författare): Department of Surgery, Karlstad County Hospital, Karlstad, Sweden,Karlstad Cty Hosp, Dept Surg, Rosenborgsgatan 9, S-65230 Karlstad, Sweden.

Dyrke, U. (författare): Department of Surgery, Falun County Hospital, Falun, Sweden,Falun Cty Hosp, Dept Surg, S-79182 Falun, Sweden.,Falun Central Hospital

Papantoniou, D. (författare): Department of Oncology, Ryhov County Hospital, Jönköping, Sweden,Ryhov Cty Hosp, Dept Oncol, S-55185 Jönköping, Sweden.

Sundin, Anders, 1954- (författare): Uppsala University,Uppsala universitet,Radiologi,Uppsala Univ, Sweden

Ullenhag, Gustav (författare): Uppsala University,Uppsala universitet,Experimentell och klinisk onkologi,Uppsala University Hospital,Uppsala Univ, Sweden; Uppsala Univ Hosp, Sweden

Hansson, Johan (författare): Karolinska Institutet

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2020-12-07
2020
Engelska.
Ingår i: BMC Cancer. - : Springer Science and Business Media LLC. - 1471-2407. ; 20:1

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Tidskriftsartikel (refereegranskat)

Abstract Ämnesord

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BackgroundThe 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 3years by clinical examinations only.MethodsThe 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 5years. 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 3years +/- 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.DiscussionThis 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.ResultsThe first patient was recruited in June 2017 and as of April 2020, almost 500 patients had been included at 19 centers in Sweden.Trial registrationClinicalTrials.gov, NCT 03116412. Registered 17 April 2017, https://clinicaltrials.gov/ct2/show/study/NCT03116412

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)

Nyckelord

Cutaneous malignant melanoma
Follow-up
FDG-PET
CT
CT
hospital anxiety
cancer
depression
qlq-c30
Oncology
CT
FDG-PET/CT

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