Assessing the role of imaging in follow-up after surgery for high-risk melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.