Comparing single and two-stage surgeries for thin 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 national, multicenter, prospective, randomized, and controlled study aims to improve the management of patients diagnosed with thin melanoma (≤1 mm Breslow thickness). The researchers will compare the outcomes of single wide local excisions (WLEs) versus traditional two-stage excisions to determine if the surgical approach affects the risk of recurrence over a follow-up period of 5 to 10 years. The study is designed to address the economic burden of melanoma treatment by potentially reducing unnecessary surgeries while maintaining patient safety and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients need to fulfill all criteria listed below:

* Has recently been diagnosed with a primary invasive cutaneous melanoma of Breslow thickness ≤1.0 mm (pT1) as determined by a diagnostic excision with subsequent histopathological analysis that:

  1. Is located on a body location in which a WLE with a 10-mm clinical margin is feasible and would have been planned according to current standard of care.
  2. Had histopathologically verified free margins of at least 1.5 mm.
* Is 18 years or older at time of consent.
* Is able to give informed consent and comply with the treatment protocol and follow-up plan.
* Has a life expectancy of ≥5 years from the time of diagnosis.

Exclusion Criteria:

If any of the listed criteria below are present, the patient is ineligible for study participation.

The study lesion:

* was partially biopsied prior to the diagnostic excision.
* was diagnostically excised with a clinical margin \>5 mm.
* was a melanoma of desmoplastic or lentiginous (i.e. lentigo maligna or acral lentiginous) subtype.
* was located on digits in which amputation is necessary.

The patient:

* had a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous).
* had physical, clinical, radiographic or pathologic evidence of microsatellite, satellite, in-transit, regional or distant metastatic melanoma.
* had a previous or intercurrent treated solid tumor or hematologic malignancy during the past 5 years except cutaneous squamous cell carcinoma or basal cell carcinoma.
* has planned adjuvant radiotherapy to the primary melanoma site after WLE.

Where it's running

• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting

Study contacts

• Principal investigator: John Paoli, Professor — Dept. of Dermatology and Venereology, Sahlgrenska Academy, University of Gothenburg, Sweden
• Study coordinator: John Paoli, Professor
• Email: john.paoli@vgregion.se
• Phone: 0730404044

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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.