About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age.
Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
Sufficient renal function for i.v. contrast scannings.
Disqualifiers
The patient is assessed as unfit to receive treatment in the case of recurrence.
Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
Inability to provide informed consent or refusal to do so.
Inability to comply with the control or intense follow-up program.
Trial design
Parallel
Treatments tested in this trial
CT or PET scans
Procedure/SurgeryScans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
Measured from date of inclusion
Secondary outcomes
Quality of life/QLQ30
Question of Life Questionnaire (QLQ) 30
Quality of life/HAD
Hospital, Anxiety and Depression (HAD) scale
Other outcomes
Disease free survival (DFS)
Sponsors and contacts
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