Actively Recruiting
Led by Uppsala University · Updated on 2024-12-16
1300
Participants Needed
20
Research Sites
N/A
Total Duration
Researchers are investigating whether regular radiological assessments during follow-up after surgery for high-risk malignant melanoma improve patient survival. The study addresses concerns about the resource demands, potential radiation exposure, and anxiety caused by such imaging, especially given the recent introduction of effective medical treatments for melanoma. There is currently no clear evidence supporting routine imaging in this context. Participants are randomly assigned to one of two groups. One group follows national guidelines with regular doctor appointments for 3 years, while the other group receives the same follow-up plus additional whole-body CT or PET scans and blood tests at baseline, 6, 12, 24, and 36 months. An interim analysis will be done after 1,000 patients enroll. During the study, researchers will monitor overall survival at 5 years as the primary outcome. They will also assess quality of life through questionnaires over the 3-year follow-up. Participants will attend scheduled visits for clinical evaluations, imaging, and blood tests, with the study aiming to provide clear evidence about the role of imaging in post-surgical melanoma care.
CONDITIONS
A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 years
Participants are assigned to routine follow-up or follow-up with additional radiological assessments including CT or PET scans and blood tests.
5 visits for scans and blood tests at baseline, 6, 12, 24, and 36 months
Duration - Up to 3 years
Participants continue follow-up with regular doctor's appointments according to national guidelines for ongoing assessment.
Regular doctor’s appointments as per national guidelines
Total: 20 locations
1
Södra Älvsborgs sjukhus
Borås, Sweden
Terminated
2
Mälarsjukhuset Eskilstuna
Eskilstuna, Sweden
Actively Recruiting
3
Falu lasarett
Falun, Sweden
Actively Recruiting
4
Gävle sjukhus
Gävle, Sweden
Actively Recruiting
5
Department of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
6
Helsingborgs lasarett
Helsingborg, Sweden
Actively Recruiting
7
Länssjukhuset Ryhov
Jönköping, Sweden
Actively Recruiting
8
Länssjukhuset i Kalmar
Kalmar, Sweden
Not Yet Recruiting
9
Centralsjukhuset i Karlstad
Karlstad, Sweden
Actively Recruiting
10
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
11
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
12
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
13
Skaraborgs sjukhus Skövde
Skövde, Sweden
Terminated
14
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
15
Länssjukhuset Sundsvall
Sundsvall, Sweden
Actively Recruiting
16
Uddevalla sjukhus
Uddevalla, Sweden
Terminated
17
Umeå University Hospital
Umeå, Sweden
Terminated
18
Akademiska sjukhuset
Uppsala, Sweden
Actively Recruiting
19
Västmanlands sjukhus Västerås
Västerås, Sweden
Actively Recruiting
20
Visby lasarett
Visby, Sweden
Actively Recruiting
G
Gustav J Ullenhag, professor
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Cecilia O Ladjevardi, Ylva Naeser, Ulf Dyrke...
https://pubmed.ncbi.nlm.nih.gov/41167217Ylva Naeser, Hildur Helgadottir, Yvonne Brandberg...
https://pubmed.ncbi.nlm.nih.gov/33287744