It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.
The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,300
Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
Södra Älvsborgs sjukhus
Borås, Sweden
TERMINATEDMälarsjukhuset Eskilstuna
Eskilstuna, Sweden
Overall survival
Measured from date of inclusion
Time frame: At 5 years
Quality of life/QLQ30
Question of Life Questionnaire (QLQ) 30
Time frame: During the 3 year intervention period
Quality of life/HAD
Hospital, Anxiety and Depression (HAD) scale
Time frame: During the 3 year intervention period
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