Assessing the role of imaging in follow-up after surgery for high-risk melanoma
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
This study is testing if adding imaging tests like CT or PET scans during follow-up after surgery can help people with high-risk melanoma live longer compared to just regular doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Locations | 20 sites (Borås and 19 other locations) |
| Trial ID | NCT03116412 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates whether radiological assessments, such as whole body CT or PET scans, during follow-up after radical surgery for high-risk malignant melanoma can improve patient survival. Patients are randomly assigned to either routine follow-up with regular doctor appointments or the same follow-up with added imaging and blood tests. The study aims to determine the effectiveness of these imaging techniques in enhancing patient outcomes while considering the potential risks and resource demands associated with them. An interim analysis will be conducted after enrolling 1000 patients to assess preliminary results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone radical surgery for stage IIb-c and III cutaneous malignant melanoma.
Not a fit: Patients who are unfit for treatment in case of recurrence or have a life expectancy of less than 2 years due to concurrent diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence on the effectiveness of imaging in improving survival rates for patients with high-risk melanoma.
How similar studies have performed: While the approach of using imaging in follow-up care is common, this specific trial addresses a gap in evidence regarding its impact on survival, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Borås and 19 other locations
- Södra Älvsborgs sjukhus — Borås, Sweden (Terminated)
- Mälarsjukhuset Eskilstuna — Eskilstuna, Sweden (Recruiting)
- Falu lasarett — Falun, Sweden (Recruiting)
- Gävle sjukhus — Gävle, Sweden (Recruiting)
- Department of Surgery, Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Helsingborgs lasarett — Helsingborg, Sweden (Recruiting)
- Länssjukhuset Ryhov — Jönköping, Sweden (Recruiting)
- Länssjukhuset i Kalmar — Kalmar, Sweden (Not_yet_recruiting)
- Centralsjukhuset i Karlstad — Karlstad, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Skaraborgs sjukhus Skövde — Skövde, Sweden (Terminated)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Länssjukhuset Sundsvall — Sundsvall, Sweden (Recruiting)
- Uddevalla sjukhus — Uddevalla, Sweden (Terminated)
- Umeå University Hospital — Umeå, Sweden (Terminated)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
- Västmanlands sjukhus Västerås — Västerås, Sweden (Recruiting)
- Visby lasarett — Visby, Sweden (Recruiting)
Study contacts
- Principal investigator: Gustav Ullenhag, associate professor — Uppsala University Hospital
- Study coordinator: Gustav J Ullenhag, professor
- Email: Gustav.Ullenhag@IGP.uu.se
- Phone: +46186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.