A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

Recruiting now · Not applicable

Conditions studied: Malignant Melanoma

In brief

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.

Key facts

Study ID

NCT03116412

Run by

Uppsala University

People needed

1300

Starts

2017-06-08

Expected to finish

2028-12-31

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Participation in other clinical trials interfering with the control-program.
• Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
• Pregnancy or currently planned pregnancy.

Where it is running

• Visby lasarett — Visby, Sweden (enrolling)
• Mälarsjukhuset Eskilstuna — Eskilstuna, Sweden (enrolling)
• Falu lasarett — Falun, Sweden (enrolling)
• Gävle sjukhus — Gävle, Sweden (enrolling)
• Department of Surgery, Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
• Helsingborgs lasarett — Helsingborg, Sweden (enrolling)
• Länssjukhuset Ryhov — Jönköping, Sweden (enrolling)
• Örebro University Hospital — Örebro, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Sweden (enrolling)
• Länssjukhuset Sundsvall — Sundsvall, Sweden (enrolling)
• Akademiska sjukhuset — Uppsala, Sweden (enrolling)
• Västmanlands sjukhus Västerås — Västerås, Sweden (enrolling)
• Centralsjukhuset i Karlstad — Karlstad, Sweden (enrolling)
• Linköping University Hospital — Linköping, Sweden (enrolling)
• Skåne University Hospital — Malmö, Sweden (enrolling)
• Länssjukhuset i Kalmar — Kalmar, Sweden
• Skaraborgs sjukhus Skövde — Skövde, Sweden
• Umeå University Hospital — Umeå, Sweden
• Södra Älvsborgs sjukhus — Borås, Sweden
• Uddevalla sjukhus — Uddevalla, Sweden

Full record on ClinicalTrials.gov

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