Comparing one-stage and two-stage surgery for thin melanoma
Tests whether a second wider skin removal is needed after thin melanoma surgery.
Plain-language title generated from the registry record
Registry title: WoW - Single- vs Two-staged Excisions of Thin Melanoma
Key facts
- Where
- Gothenburg, SwedenSee the site
Where in Sweden
- Sahlgrenska University HospitalGothenburg, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vastra Gotaland Region
- Trial code
- NCT06363591
- Record updated
- 5 March 2025
- Original description
The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period.Read full original descriptionShow less
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
The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period.
Inclusion: 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:; 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; 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: was partially biopsied prior to the diagnostic excision; had a previous or concurrent MIS or invasive melanoma (cutaneous or non-cutaneous); 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; If any of the listed criteria below are present, the patient is ineligible for study participation; The study lesion:; 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 physical, clinical, radiographic or pathologic evidence of microsatellite, satellite, in-transit, regional or distant metastatic melanoma.