Actively Recruiting
WoW - Single- vs Two-staged Excisions of Thin Melanoma
Led by Vastra Gotaland Region · Updated on 2025-03-05
2486
Participants Needed
1
Research Sites
779 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
WoW - Single- vs Two-staged Excisions of Thin Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recently diagnosed with primary invasive cutaneous melanoma with Breslow thickness 641.0 mm confirmed by diagnostic excision
- Melanoma located where a wide local excision with a 10-mm clinical margin is feasible and planned
- Histopathologically verified free margins of at least 1.5 mm from diagnostic excision
- 18 years or older at time of consent
- Able to give informed consent and follow the treatment and follow-up plan
- Life expectancy of at least 5 years from diagnosis
You will not qualify if you...
- Melanoma lesion partially biopsied before diagnostic excision
- Diagnostic excision performed with clinical margin greater than 5 mm
- Melanoma of desmoplastic or lentiginous subtype (including lentigo maligna or acral lentiginous)
- Melanoma located on digits requiring amputation
- Previous or concurrent melanoma (cutaneous or non-cutaneous), including melanoma in situ
- Evidence of metastatic melanoma (microsatellite, satellite, in-transit, regional, or distant)
- Previous or treated solid tumor or blood cancer within past 5 years, except certain skin cancers
- Planned adjuvant radiotherapy to the primary melanoma site after wide local excision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345
Actively Recruiting
Research Team
J
John Paoli, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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