Comparing single and two-stage surgeries for thin melanoma
Wise vs Wide: A National, Multicenter, Prospective, Randomized and Controlled, Parallel Group, Non-inferiority Study to Compare Single- vs Two-staged Excisions of Thin Melanoma
This study is testing whether one surgery or two surgeries for thin melanoma can lower the chances of the cancer coming back for patients over the next 5 to 10 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2486 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT06363591 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently been diagnosed with primary invasive cutaneous melanoma of Breslow thickness ≤1.0 mm with verified free margins.
Not a fit: Patients with melanoma lesions that were partially biopsied or excised with a clinical margin greater than 5 mm will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient surgical management of thin melanoma, reducing the need for multiple surgeries and associated healthcare costs.
How similar studies have performed: Other studies have explored surgical approaches for melanoma, but this specific comparison of single versus two-stage excisions in thin melanoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gothenburg
- 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
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.